FDA Adverse Event
Malfunction
Summary report: N
POWER PRO AMBULANCE COT
MDR report key: 2182048
·
Received June 22, 2011
Report
- Report Number
- 1831750-2011-06335
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 25, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
OTHER: WHEEL ASSEMBLY; LOAD WHEEL ON HEAD SECTION ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD SECTION LOAD WHEELS WERE DAMAGED, THE WHEELS WERE WORN AND DAMAGED, AND THE RETAINING POST WAS LOOSE. THERE WERE EXPOSED SHARP EDGES. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWER PRO AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL | 6500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |