FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHLOBS3/07
MDR report key: 3231246
·
Received July 17, 2013
Report
- Report Number
- 0001831750-2013-06421
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 19, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT HOLDING DUE TO DAMAGED BRAKE CAMS. 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 |
|---|---|---|---|---|---|---|---|
| 331491 | SM104 MSERIES W5TH WHLOBS3/07 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |