FDA Adverse Event
Malfunction
Summary report: N
ADVANTAGE SERIES 29 OBS10/04
MDR report key: 2990859
·
Received March 6, 2013
Report
- Report Number
- 0001831750-2013-01768
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 11, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT HOLDING AT THE FOOT END OF THE STRETCHER DUE TO A BRAKE ADJUSTER THAT WAS OUT OF ADJUSTMENT. HOWEVER, THE BRAKES WERE STILL HOLDING ON THE HEAD-END. 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 |
|---|---|---|---|---|---|---|---|
| 95859 | ADVANTAGE SERIES 29 OBS10/04 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |