FDA Adverse Event
Malfunction
Summary report: N
SYSTEM CONSOLE
MDR report key: 4173756
·
Received October 15, 2014
Report
- Report Number
- 1045834-2014-14046
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Report Date
- November 26, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- PK080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE 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. DEVICE CAME IN FOR SERVICE AND WAS REPAIRED BY TECHNICIAN. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A PROBLEM WITH THE POWER SUPPLY BECAUSE IT WOULD SHUT OFF AND RESTART AFTER 20 SECONDS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654239 | SYSTEM CONSOLE | MOTOR, DRILL, ELECTRIC - CONSOLE | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |