FDA Adverse Event
Malfunction
Summary report: N
INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
MDR report key: 3202125
·
Received June 28, 2013
Report
- Report Number
- 3006697299-2013-00055
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Report Date
- June 28, 2013
- Manufacturer
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Product Code
- GWM
- PMA / PMN Number
- K121573
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CAM02 POWER CORD HAD A SHORT IN IT. THE INTEGRA SALES REP FOUND THE BAD CORD DURING AN IN SERVICE HAS WAS PROVIDING TO THE INTENSIVE CARE UNIT STAFF. THERE WAS NO PT CONTACT AND NO INJURY INVOLVED WITH THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295886 | INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR | ICP MONITORING | GWM | INTEGRA LIFESCIENCES (IRELAND) LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |