FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 2133185
·
Received May 4, 2011
Report
- Report Number
- 1831750-2011-04320
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 6, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE EVALUATION CODING PROVIDED WAS BASED UPON THE CUSTOMER'S REPORT. THEY HAVE REQUESTED A REPLACEMENT JACK TO REPAIR THE STRETCHER THEMSELVES.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE JACK IS DRIFTING DOWN, WON'T STAY PUMPED UP. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |