FDA Adverse Event
Malfunction
Summary report: N
SM104 M-SERIES W/5TH WHEEL
MDR report key: 2072681
·
Received April 21, 2011
Report
- Report Number
- 1831750-2011-03867
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 24, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVALUATION WAS PERFORMED BY THE CUSTOMER AND A REPLACEMENT GAS CYLINDER ORDERED TO REPAIR THE STRETCHER. THE EVALUATION CODES PROVIDED ARE BASED UPON THE CUSTOMER'S REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER GAS SPRING WAS LEAKING AND THE FOWLER WOULD NOT GO UP AND DOWN. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 M-SERIES W/5TH WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1007 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |