FDA Adverse Event
Malfunction
Summary report: N
POWER MODULE F/TRS
MDR report key: 3941384
·
Received July 17, 2014
Report
- Report Number
- 8030965-2014-00487
- Event Type
- Malfunction
- Date Received
- July 17, 2014
- Report Date
- November 22, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- MOQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES (B)(6) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INSPECTION OF DEVICE REVEALED LIQUID WITHIN THE HOUSING DUE TO IMPROPER MAINTENANCE AND CARE WHILE CLEANING. THE DEVICE WAS REPLACED AND SENT TO CUSTOMER ON (B)(6) 2012. (B)(6). PLACEHOLDER.
Description of Event or Problem · 1
CUSTOMER REPORTED THE DEVICE NO LONGER WORKED AFTER THE DRIVE UNIT OVERHEATED. THIS IS REPORT 1 OF 1 FOR #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418732 | POWER MODULE F/TRS | MOQ | SYNTHES GMBH | 8724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |