SIEMENS HEALTHINEERS FORM FOR POTENTIAL COMPLAINTS

General Q/A:

Q. When should I use this form?

A. This form should be used to document PPIs or PSIs involving Siemens devices ONLY when access to other channels for submitting potential
complaints (i.e. web complaint input form, SAP, Siebel, or Service handheld) are not available /accessible. If you become aware of a PSI or PPI,
please complete this form and submit it to your Country quality organization/representative or the Healthcare Business Line (HBL) or
Healthcare Business Area (HBA) responsible for the product.

Q. What is a complaint?
A. A complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability,
safety, effectiveness, or performance of a Siemens medical device after it has been released for distribution. Please note that once you are
informed or become knowledgeable of an issue that meets the definition of a complaint you are required to complete this form within 2
business days (or earlier if other local regulatory requirements apply).

Q. What is Potential Safety Issue (PSI)?

A. Any safety related issue or any assumption by the customer, user or other person of an alleged safety situation is considered as a PSI. In
addition, any malfunction or deterioration in the characteristics and/or performance and/or effectiveness of a device reported by the
customer, user or other person which directly or indirectly, may cause or contribute, or has caused or contributed, to a death or serious injury
is considered a PSIs. PSIs include, but are not limited to, reports of actual patient injury or death. If you become aware of a PSI, please
complete this form and submit it to your Country quality organization/representative or Healthcare Business Line (HBL) or Healthcare
Business Area (HBA) responsible for the product.

Q. What is considered a Potential Product Issue (PPI)?

A. Any alleged product issue, related to performance or effectiveness, of a Siemens Healthcare medical device after it is released for
distribution. PPIs do not involve safety related events. If you become aware of a PPI, please complete this form and submit it to your Country
quality organization/representative or the Healthcare Business Line (HBL) or Healthcare Business Area (HBA) responsible for the product.

Q. Who should complete the Potential Complaint Form?

A. The Siemens employee/Distributor or Business Partner who has become aware of a potential complaint is required to complete this form.
This is for internal (and approved external) use only. DO NOT provide or redistribute this form to customers to complete.
Note: This form should be used to document PPIs or PSIs involving Siemens devices ONLY when access to other channels for submitting
potential complaints (i.e. web complaint input form, SAP, Siebel, or Service handheld) are not available /accessible

Q. When should I submit this form?

A. If you become aware of a PSI or PPI, please complete this form and submit it to your Country quality organization/representative or the
Healthcare Business Line (HBL) or Healthcare Business Area (HBA) responsible for the product.

Q. What fields should be filled out before I submit the form?

A. You should complete the sections that apply to the issue type, PSI or PPI, which you are reporting. Provide all the information available to
you. Every field with a Red asterisks (*) is mandatory. At a minimum, Sections 1 and 2 must be completed.

Q. Where should I send the completed Potential Complaint Form?

A. Submit it to your Country quality organization/representative or the Healthcare Business Line (HBL) or Healthcare Business Area (HBA)
responsible for the product.

Healthcare Business Line (HBL) or Healthcare Business Area (HBA) Email

AT Siemens Healthineers AT Complaint at-complaint.team@siemens-healthineers.com
AT-PT Siemens Healthineers AT PT Complaint complaint-pt-dcu.team@siemens-healthineers.com
AT-RO Siemens Healthineers AT RO Complaint himcrrocomplaint.healthcare@siemens.com
CT Siemens Healthineers CT Complaint imcrct-complaint.healthcare@siemens.com
CV Siemens Healthineers CV Complaint CPCVOEMCOMPLAINT.team@siemens-healthineers.com
MI Siemens Healthineers MI Complaint nmgregulatoryaffairs.healthcare@siemens.com
MR Siemens Healthineers MR Complaint mr-complaint.team@siemens-healthineers.com
SSME CT Siemens Healthineers SSME CT Complaint SSMECT-Complaint.Healthcare@siemens.com
SSME XP Siemens Healthineers SSME Complaint SSMEXPComplaint.healthcare@siemens.com
SSMR Siemens Healthineers SSMR Complaint smmr-qm.healthcare@internal.siemens.com
SSMR AT Siemens Healthineers SSMR AT Complaint SSMRAX-Complaint.healthcare@siemens.com
SYNGO Siemens Healthineers SYNGO Complaint syngo-complaint.team@siemens-healthineers.com
DS Siemens Healthineers DS Complaint syngo-complaint.team@siemens-healthineers.com
US Siemens Healthineers US Complaint usd-complaint.healthcare@siemens.com
XP Siemens Healthineers XP Complaint xp-complaint.healthcare@siemens.com
LD/PoC/MDx Follow the standard escalation process for complaints as defined in relevant contractual agreements or contact
your Siemens support representative for guidance on where to send this form.

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 SIEMENS HEALTHINEERS FORM FOR POTENTIAL COMPLAINTS
* indicates mandatory fields / Please type or print clearly! / Attach additional blank pages if you run out of space.
Section 1

Issue Type* X Potential Product Issue (complete section 1 &2) ☐ Potential Safety Issue (complete section 1, 2 & 3a or 3b)
Business Area / Line*: ☐AX ☐CT ☐MI ☐MR ☐US ☐RO ☐SY ☐DS ☐XP ☐PT ☐LD X POC ☐MDX
Issue initiated by*: X Customer ☐Healthineers internal ☐Siemens 3rd party supplier (customer in GSMS)
Preparer*: Name: Office phone: Mobile phone: Email:
Hac Khanh Huy 0915783162 huyhk@ptmedical.com.vn
Customer*: Customer / Institution: Customer Contact Name: Phone: Address:
Binh Chanh Ms.Huong 01673084415
Hospital
Configuration item Functional Location: Material No.: Serial No.: Material description: SW Ver.:
(equipment) *: Laboratory D722 1.5
Affected Component: SW/Lot/Part: Material No.: Serial No.: Material description:
Ph Sensor 10312556
Reference Sensor 10323084
Nature of issue: ☐Application ☐Computer ☐Assay X Hardware ☐Software
Section 2
Description: Short description* (max 120 characters): What is the problem?*:
Ph calibration is failed Install Po2, Pco2, Ph,Na, reference sensor.
Run deproteiner and conditioner.
Run calibration, Ph is always no endpoint.
Checked at another BG, everything was ok.
Include Ph, Na, Reference sensor, buffer 6.8/7.3.

When does it occur?*: What has been done so far? *

05/09/2018

Related tickets: Customer Reference No.: T000191015

Dates: Date of (First) Event*: D213: 15/08/2 Date Healthineers notified*:

Damage to property other than equipment involved? ☐yes X no ☐unknown

Description:

Were accessories other than those ☐yes X no ☐unknown

recommended by Siemens used?
Description:

Were parts replaced for this issue? ☐yes X no ☐unknown ☐na

Material number Serial number Comp. descr. SW Version Returned on In Siemens possession?

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 SIEMENS HEALTHINEERS FORM FOR POTENTIAL COMPLAINTS

Section 3a - Potential Safety issue (PSI) for in vivo imaging products (AX – CT – MI – MR – US – RO – SY – DS – XP – PT)
Did customer inform a regulatory authority?* ☐yes ☐no ☐unknown
Was there any injury (even slightly) or death?* ☐yes ☐no ☐unknown
Extent of injury:

Identity (of injured person) ☐Patient ☐Operator ☐Siemens Employee ☐Other ☐NA
Age: Sex: Weight (inc. unit):
Do you think this may be a case of Accidental Radiation ☐yes ☐no ☐unknown
Occurrence (ARO)?
Description:

Did the injury necessitate medical intervention? ☐yes ☐no ☐unknown By whom?

Description:

Was the device being used to treat or diagnose patient during ☐yes ☐no ☐unknown
the event?
Was there an actual device failure to perform within the ☐yes ☐no ☐unknown
specifications during event?

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 SIEMENS HEALTHINEERS FORM FOR POTENTIAL COMPLAINTS
Section 3b - Potential Safety issue (PSI) for in vitro Diagnostic Products (LD / POC / MDX)
Did customer inform a regulatory authority?* ☐yes ☐no ☐unknown
Occupation of person reporting the initial event*:
Please choose one of the following to describe primary event ☐Death ☐Injury/Illness (or potential)
that occurred*:
☐Potential Hazard (Leak, Fire) ☐ARO (Accidental Radiation)
☐Unflagged error ☐Malfunction (HW, SW, Assay)
☐Flagged error ☐Non-standard use
☐Discordant Result(s) ☐Other
Frequency of occurrence*:
Who was affected? ☐Patient ☐Operator ☐Siemens Employee ☐Other ☐NA
Patient/ User Identifier (SID/PID/ACCN):

(do NOT include or attach data that can directly identify the patient.) Age: Sex:
Medications being taken at the time of the event:

Did the patient/ User have any pre-existing medical ☐yes ☐no ☐unknown If yes,
conditions? please list all:
Was the cause related to an instrument malfunction?* ☐yes ☐no ☐unknown
Was the cause related to lack of required customer ☐yes ☐no ☐unknown
maintenance?*
If Patient results were affected, were the initial results ☐yes ☐no ☐unknown ☐NA
reported to the physician?*
If reported, did the physician question the results? ☐yes ☐no ☐unknown
Is it alleged that a medical procedure or treatment, that may later ☐yes ☐no ☐unknown
be determined to have been unnecessary, was performed?*
If yes, what was the procedure or treatment? Be specific!
Is it alleged that the test result caused a medical procedure, ☐yes ☐no ☐unknown If yes, please
which may later be determined to have been necessary, to be describe the
delayed or withheld? * procedure:
Is it alleged that harm to the user or patient was caused ☐yes ☐no ☐unknown If yes, please
related to the use of the device? * describe the
(Regardless of whether the device is at fault or not) event:
Was repeat testing performed to confirm correct results?* ☐yes ☐no
If yes, was a different sample utilized for the repeat testing? ☐yes ☐no
Was a different instrument utilized for the repeat testing? ☐yes ☐no
If yes, what instrument was utilized for the repeat testing?
What gave confidence that the repeat results were correct?
Were other clinical diagnostic tests performed? * ☐yes ☐no If yes, please list
tests and
results:
Was a corrected report issued? ☐yes ☐no
Assay Involved:
Catalog Number:
Lot Number:
Expiration Date:
Initial Result:
Repeated Result(s):
Result Units:
If multiple results, please include a table (e.g. Initial Result / Repeat result (same sample) / Repeat result (new sample) / Instrument result was obtained on (Same or specify which if different)

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