FDA Adverse Event
Malfunction
Summary report: N
OEM STRETCHER CONFIGS -OBS2010
MDR report key: 2925710
·
Received January 22, 2013
Report
- Report Number
- 0001831750-2013-00289
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- January 3, 2013
- Report Date
- January 3, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BRAKE CAMS.
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS FOR A DEVICE THAT IS MANUFACTURED BY ANOTHER MANUFACTURER. A LETTER WAS SENT TO THE MANUFACTURER OF THIS DEVICE INFORMING THEM OF THE ALLEGED COMPLAINT INVOLVING THIS DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT STAYING ENGAGED.
Description of Event or Problem · 1
THIS COMPLAINT IS FOR A DEVICE THAT IS MANUFACTURED BY ANOTHER MANUFACTURER. A LETTER WAS SENT TO THE MANUFACTURER OF THIS DEVICE INFORMING THEM OF THE ALLEGED COMPLAINT INVOLVING THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29165 | OEM STRETCHER CONFIGS -OBS2010 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 0722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |