FDA Adverse Event
Malfunction
Summary report: N
PRIME ZOOM STRETCHER, ELECTRIC
MDR report key: 2932829
·
Received December 28, 2012
Report
- Report Number
- 1831750-2012-13436
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 3, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ZOOM; CAM POSITION CABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM FUNCTION WAS INTERMITTENT. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIME ZOOM STRETCHER, ELECTRIC | POWERED WHEELED STRETCHER | INK | STRYKER MEDICAL | 1125000000E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |