FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHLOBS3/07
MDR report key: 3233995
·
Received July 18, 2013
Report
- Report Number
- 0001831750-2013-06454
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 24, 2013
- Report Date
- June 24, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 WORN BRAKE RINGS AND WORN WHEELS. ALSO, THE SCALE WAS INACCURATE DUE TO MALFUNCTIONED LOAD CELL. 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 |
|---|---|---|---|---|---|---|---|
| 334152 | SM104 MSERIES W5TH WHLOBS3/07 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |