FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 2033210
·
Received February 28, 2011
Report
- Report Number
- 1831750-2011-01982
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- January 31, 2011
- Report Date
- January 31, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
OTHER: GAS SPRING TIP.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE GAS SPRING TIP HAD BENT CAUSING THE FOWLER NOT TO WORK PROPERLY. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |