FDA Adverse Event
Malfunction
Summary report: N
GYNNIE OB-GYN STRETCHER
MDR report key: 3261037
·
Received August 2, 2013
Report
- Report Number
- 0001831750-2013-06923
- Event Type
- Malfunction
- Date Received
- August 2, 2013
- Date of Event
- May 1, 2013
- Report Date
- July 10, 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 BE PROPERLY ENGAGED DUE TO DAMAGED BRAKE ADJUSTER, DAMAGED BRAKE RING AND MISSING CASTER COVERS. 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 |
|---|---|---|---|---|---|---|---|
| 362761 | GYNNIE OB-GYN STRETCHER | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |