FDA Adverse Event
Malfunction
Summary report: N
ST104 TRANSPORT
MDR report key: 2243268
·
Received September 1, 2011
Report
- Report Number
- 1831750-2011-09395
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 4, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAILS WERE WOBBLY AND THE SIDERAIL COULD UNLATCH DURING MOVEMENT OF THE STRETCHER. THE CUSTOMER COULD NOT DETERMINE IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ST104 TRANSPORT | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 0735 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |