FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHL
MDR report key: 2120011
·
Received May 26, 2011
Report
- Report Number
- 1831750-2011-05133
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- April 28, 2011
- Report Date
- April 28, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Removal / Correction Number
- Z-226-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVAL RESULT: BRAKE CAM.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE BRAKES WERE NOT HOLDING. IN ADDITION THE TOP RAIL WAS BROKEN PRESENTING SHARP EDGES AT THE PT FOOT END. 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 MEDICAL | 1005 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |