FDA Adverse Event
Malfunction
Summary report: N
POWER PRO AMBULANCE COT
MDR report key: 3051424
·
Received April 10, 2013
Report
- Report Number
- 0001831750-2013-03163
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE COT COULD NOT BE LOCKED INTO THE FASTENING SYSTEM DUE TO THE RETAINING POST FALLING OFF AS A RESULT OF A MISSING FASTENER ON THE LOWER CROSS TUBE FRAME. 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 |
|---|---|---|---|---|---|---|---|
| 149922 | POWER PRO AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |