FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHL
MDR report key: 2110188
·
Received May 19, 2011
Report
- Report Number
- 1831750-2011-04878
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 22, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULT: LATCH HANDLE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BOTH LEFT/RIGHT RAILS CAN'T LOCK IN THE UP POSITION. THE TOP RAILS ARE BROKEN AND THE LATCH HANDLES ARE EITHER MISSING OR BROKEN. THERE ARE SHARP SURFACES PRESENT. NO PATIENT 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 |