FDA Adverse Event
Malfunction
Summary report: N
POWER PRO AMBULANCE COT
MDR report key: 3250361
·
Received July 26, 2013
Report
- Report Number
- 0001831750-2013-06735
- Event Type
- Malfunction
- Date Received
- July 26, 2013
- Date of Event
- July 3, 2013
- Report Date
- July 3, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE COT DROPPED DUE TO POTENTIAL USER ERROR. DEVICE EVALUATED, NO MALFUNCTION FOUND, INSTRUCTED THE CUSTOMER ON HOW TO PROPERLY UNLOAD THE UNIT FROM THE AMBULANCE. 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 |
|---|---|---|---|---|---|---|---|
| 351315 | POWER PRO AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |