FDA Adverse Event
Malfunction
Summary report: N
DX AMBULANCE COT
MDR report key: 2232808
·
Received July 19, 2011
Report
- Report Number
- 1831750-2011-07201
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 20, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESTRAINT STRAPS.
Description of Event or Problem · 1
IT IS REPORTED THAT THE RESTRAINT STRAPS WERE MALFUNCTIONING. THERE WAS NO REPORTED PT INVOLVEMENT OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DX AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL | 6060 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |