FDA Adverse Event
Malfunction
Summary report: N
POWER PRO AMBULANCE COT
MDR report key: 2111316
·
Received May 18, 2011
Report
- Report Number
- 1831750-2011-04834
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 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
BURRS ON SAFETY BAR; LAP BELT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE RESTRAINT STRAPS WERE WORN AND THE LAP STRAPS WERE INCORRECTLY LOCATED AROUND THE PLASTIC HINGE. ADDITIONALLY, IT WAS REPORTED THERE WERE BURRS ON THE SAFETY BAR. 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 |