FDA Adverse Event
Malfunction
Summary report: N
POWER PRO AMBULANCE COT
MDR report key: 2191599
·
Received July 1, 2011
Report
- Report Number
- 1831750-2011-06688
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 6, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT : MID-GATCH SUPPORT BRACKET.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KNEE GATCH STRAPPING HAS CAUSED THE PLASTIC PIECES UNDERNEATH OF IT TO BREAK. EVAL FOUND THAT THERE WERE SHARP EDGES ON MID-GATCH SUPPORT BRACKET. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE 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 |