FDA Adverse Event
Malfunction
Summary report: N
1188 HD CCU
MDR report key: 2640399
·
Received June 27, 2012
Report
- Report Number
- 2936485-2012-00350
- Event Type
- Malfunction
- Date Received
- June 27, 2012
- Date of Event
- June 7, 2012
- Report Date
- June 7, 2012
- Manufacturer
- STRYKER ENDOSCOPY - SAN JOSE
- Product Code
- FXM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 UNIT DOES NOT HAVE ANY VIDEO SIGNAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1188 HD CCU | CAMERA CONTROL UNIT | FXM | STRYKER ENDOSCOPY - SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |