FDA Adverse Event
Malfunction
Summary report: N
PKG, WISE 26IN HDTV SURGICAL DISPLAY
MDR report key: 2943310
·
Received December 13, 2012
Report
- Report Number
- 2936485-2012-00596
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- November 21, 2012
- Report Date
- November 21, 2012
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- GCJ
- PMA / PMN Number
- K081995
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MONITOR FELL OFF THE ARM. THE POWER CORD AND DVI CABLE WERE THE ONLY THINGS THAT KEPT THE MONITOR FROM HITTING THE PATIENT IN THE FACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PKG, WISE 26IN HDTV SURGICAL DISPLAY | GCJ | STRYKER ENDOSCOPY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |