FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 2113447
·
Received May 25, 2011
Report
- Report Number
- 1831750-2011-05073
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 27, 2011
- Report Date
- April 27, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULT: OBJECT FOUND UNDER BASE HOOD WAS INTERFERING WITH PUMP PEDAL MOVEMENT. REMOVED OBJECT AND PUMP PEDAL FUNCTION WAS RESTORED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER WILL NOT PUMP UP AND THE ZOOM HANDLE COVERS ARE CRACKED PRESENTING SHARP EDGES. 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 | SM304 M-SERIES W/ZOOM | WHEELED POWERED STRETCHER | FPO | STRYKER MEDICAL | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |