FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHLOBS3/07
MDR report key: 3192809
·
Received June 27, 2013
Report
- Report Number
- 0001831750-2013-05841
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- May 31, 2013
- Report Date
- May 31, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD NOT REMAIN LATCHED DUE TO DAMAGED LATCH ASSEMBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293920 | SM104 MSERIES W5TH WHLOBS3/07 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |