FDA Adverse Event
Malfunction
Summary report: N
CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT
MDR report key: 3955788
·
Received June 25, 2014
Report
- Report Number
- 8010219-2014-00028
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Report Date
- June 4, 2014
- Manufacturer
- INTEGRA NEUROSCIENCES, LTD.
- Product Code
- GWM
- PMA / PMN Number
- K962928
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CAM01 BECAME STUCK ON THE LOGON SCREEN AND WOULD NOT FUNCTION WHEN THE CABLE WAS SWAPPED OUT. THE EVENT OCCURRED UPON FIRST BEING USED ON A PATIENT. ANOTHER UNIT WAS OBTAINED FOR USE WITHOUT ANY PROBLEM. THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THE ISSUE OR BECAUSE OF THE FEW MINUTE DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370612 | CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT | NA | GWM | INTEGRA NEUROSCIENCES, LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |