FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 1850012
·
Received September 27, 2010
Report
- Report Number
- 1831750-2010-02588
- Event Type
- Malfunction
- Date Received
- September 27, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 2, 2010
- Manufacturer
- STRYKER CORP. MEDICAL DIVISION
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER HAS ONE PEDAL WAS MISSING AND THE OTHER PEDAL DOES NOT ENGAGE DRIVE OR BRAKE. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM304 M-SERIES W/ZOOM | WHEELED POWERED STRETCHER | INK | STRYKER CORP. MEDICAL DIVISION | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |