FDA Adverse Event
Malfunction
Summary report: N
ADVANTAGE SERIES 26 OBS 10/04
MDR report key: 3180027
·
Received June 20, 2013
Report
- Report Number
- 0001831750-2013-05596
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 23, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES COULD NOT HOLD DUE TO WORN DRIVE LINK ASSEMBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279765 | ADVANTAGE SERIES 26 OBS 10/04 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |