FDA Adverse Event
Malfunction
Summary report: N
CELSIUS CONTROL CONSOLE
MDR report key: 1934765
·
Received December 19, 2010
Report
- Report Number
- 1934765
- Event Type
- Malfunction
- Date Received
- December 19, 2010
- Date of Event
- November 7, 2010
- Report Date
- December 19, 2010
- Manufacturer
- PHILIPS HEALTHCARE (INNERCOOL THERAPIES)
- Product Code
- NCX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING END OF THE REWARMING PHASE (DEVICE SET TO 36.3 DEGREES), THE DEVICE FAILED WITH AN ERROR MESSAGE READING "106 FTS". DEVICE NO LONGER MAINTAINING PT AT SET TEMPERATURE. TROUBLE-SHOOTING RECOMMENDATIONS FOLLOWED. INNERCOOL TECHNICAL SUPPORT CONTACTED - STILL UNABLE TO RESUME THERAPY. DR. CONTACTED - UNABLE TO RESUME THERAPY, DEVICE CONTINUING TO READ SAME ERROR. PT ALERT, RESPONSIVE AND APPROPRIATE AFTER THERAPY TERMINATED, NO INJURY TO PATIENT SUSPECTED. ESOPHAGEAL TEMP PROBE MAY HAVE BEEN A CONTRIBUTING FACTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELSIUS CONTROL CONSOLE | SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING | NCX | PHILIPS HEALTHCARE (INNERCOOL THERAPIES) | 10942 | * | |
| 2 | LEVEL 1 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE | NCX | SMITHS MEDICAL ASD, INC. (LEVEL 1) | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |