FDA Adverse Event
Malfunction
Summary report: N
POWER PRO AMBULANCE COT
MDR report key: 3243384
·
Received July 23, 2013
Report
- Report Number
- 0001831750-2013-06613
- Event Type
- Malfunction
- Date Received
- July 23, 2013
- Date of Event
- June 27, 2013
- Report Date
- June 27, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THERE WAS A STRIPPED BRACKET SCREW ON THE COT RETAINING POST THAT COULD POTENTIALLY CAUSE UNINTENDED COT MOTION IN THE AMBULANCE. ALSO, THERE WAS A BROKEN OUTER BASE TUBE WELDMENT THAT COULD POTENTIALLY CAUSE AN UNSTABLE COT. 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 |
|---|---|---|---|---|---|---|---|
| 342879 | POWER PRO AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |