FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHL
MDR report key: 1983662
·
Received January 31, 2011
Report
- Report Number
- 1831750-2011-00917
- Event Type
- Malfunction
- Date Received
- January 31, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 4, 2011
- Manufacturer
- STRYKER CORP, MEDICAL DIV.
- Product Code
- FPO
- Removal / Correction Number
- Z-226-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
BRAKE CAM.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE BRAKES WILL NOT HOLD. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 MSERIES W5TH WHL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP, MEDICAL DIV. | 1005 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |