FDA Adverse Event
Malfunction
Summary report: N
POWER PRO AMBULANCE COT
MDR report key: 2222495
·
Received July 13, 2011
Report
- Report Number
- 1831750-2011-07048
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 15, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
OUTER BASE TUBE WELDMENT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE LOWER OUTER BASE TUBE WELDMENT WAS BROKEN AND THE COT WOULD NOT ROLL PROPERLY. THERE WERE EXPOSED SHARP EDGES REPORTED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWER PRO AMBULANCE COT | STRETCHER, WHEELED | INK | STRYKER MEDICAL | 6500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |