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General Q/A:
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).
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.
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?
(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)