FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHLOBS3/07
MDR report key: 3181400
·
Received June 21, 2013
Report
- Report Number
- 0001831750-2013-05610
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 24, 2013
- Report Date
- May 24, 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 PATIENT SIDE RAIL CANNOT BE LATCHED IN PLACE DUE TO DAMAGED LATCH SPINDLE. 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 |
|---|---|---|---|---|---|---|---|
| 282134 | SM104 MSERIES W5TH WHLOBS3/07 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |