UNKNOWN ARCTIC SUN 5000
Report
- Report Number
- 1018233-2025-02255
- Event Type
- Malfunction
- Date Received
- April 2, 2025
- Date of Event
- March 28, 2025
- Report Date
- July 16, 2025
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- PMA / PMN Number
- K161602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED. THEY HAVE CONFIRMED THE ESOPHAGEAL PROBE WAS IN PLACE AND IT WAS VERIFIED ON IMAGING. THEY CHECKED A RECTAL TEMPERATURE, AND IT WAS 32.4C. THEY CHANGED OUT THE ESOPHAGEAL PROBE TO MAKE SURE AND IT WAS STILL 33.8C. THE WATER TEMPERATURE (WT) WAS VERY COLD 12.4C, PATIENT WAS SHIVERING, AND SKIN WAS VERY COLD. NURSE WANTED TO MAKE SURE THE DEVICE WAS WORKING APPROPRIATELY AND THERE WAS NO OTHER TROUBLESHOOTING THEY SHOULD DO. CONFIRMED THEY WOULD RECOMMEND VERIFYING THE PROBE PLACEMENT AND CHECKING IF IT CORRELATES WITH ANOTHER TEMPERATURE. THEY ALSO RECOMMEND CHANGING OUT THE PROBE IF UNSURE IT WAS ACCURATE. INFORMED NURSE DID SEE LESS LAG TIME WITH ESOPHAGEAL PROBES, WHICH MIGHT BE WHY IT WAS HIGHER THAN THE RECTAL TEMPERATURE. THE READINGS COULD BE DIFFERENT DEPENDING ON MODALITY AND PLACEMENT. DISCUSSED LOWER WATER LIMIT (LWL) AND CONFIRMED IT WAS 10C. IF THE PATIENT WAS SHIVERING AND GENERATING HEAT, THEN THE PATIENTS CORE TEMPERATURE MIGHT TRULY BE ABOVE TARGET, AND THE DEVICE WOULD CONTINUE MAKING COLD WATER TO TRY TO GET THE PATIENT DOWN TO TARGET. NURSE WOULD CONTINUE TO MONITOR AND CALL BACK IF NEEDED. THE INSTRUCTIONS-FOR-USE ARE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. A DHR REVIEW IS NOT REQUIRED AS THE SERIAL NUMBER IS UNKNOWN. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT THE NURSE STATED THAT THEY HAVE A NEONATE COOLING IN AN ARCTIC SUN DEVICE. THE TARGETED TEMPERATURE (TT) WAS 33.5C AND THE PATIENT TEMPERATURE (PT) ON THE ESOPHAGEAL PROBE WAS READING 33.8C. THEY HAVE CONFIRMED THE ESOPHAGEAL PROBE WAS IN PLACE AND IT WAS VERIFIED ON IMAGING. THEY CHECKED A RECTAL TEMPERATURE, AND IT WAS 32.4C. THEY CHANGED OUT THE ESOPHAGEAL PROBE TO MAKE SURE AND IT WAS STILL 33.8C. THE WATER TEMPERATURE (WT) WAS VERY COLD 12.4C, PATIENT WAS SHIVERING, AND SKIN WAS VERY COLD. NURSE WANTED TO MAKE SURE THE DEVICE WAS WORKING APPROPRIATELY AND THERE WAS NO OTHER TROUBLESHOOTING THEY SHOULD DO. CONFIRMED THEY WOULD RECOMMEND VERIFYING THE PROBE PLACEMENT AND CHECKING IF IT CORRELATES WITH ANOTHER TEMPERATURE. THEY ALSO RECOMMEND CHANGING OUT THE PROBE IF UNSURE IT WAS ACCURATE. INFORMED NURSE DID SEE LESS LAG TIME WITH ESOPHAGEAL PROBES, WHICH MIGHT BE WHY IT WAS HIGHER THAN THE RECTAL TEMPERATURE. THE READINGS COULD BE DIFFERENT DEPENDING ON MODALITY AND PLACEMENT. DISCUSSED LOWER WATER LIMIT (LWL) AND CONFIRMED IT WAS 10C. IF THE PATIENT WAS SHIVERING AND GENERATING HEAT, THEN THE PATIENTS CORE TEMPERATURE MIGHT TRULY BE ABOVE TARGET, AND THE DEVICE WOULD CONTINUE MAKING COLD WATER TO TRY TO GET THE PATIENT DOWN TO TARGET. NURSE WOULD CONTINUE TO MONITOR AND CALL BACK IF NEEDED.
IT WAS REPORTED THAT THE NURSE STATED THAT THEY HAVE A NEONATE COOLING IN AN ARCTIC SUN DEVICE. THE TARGETED TEMPERATURE (TT) WAS 33.5C AND THE PATIENT TEMPERATURE (PT) ON THE ESOPHAGEAL PROBE WAS READING 33.8C. THEY HAVE CONFIRMED THE ESOPHAGEAL PROBE WAS IN PLACE AND IT WAS VERIFIED ON IMAGING. THEY CHECKED A RECTAL TEMPERATURE, AND IT WAS 32.4C. THEY CHANGED OUT THE ESOPHAGEAL PROBE TO MAKE SURE AND IT WAS STILL 33.8C. THE WATER TEMPERATURE (WT) WAS VERY COLD 12.4C, PATIENT WAS SHIVERING, AND SKIN WAS VERY COLD. NURSE WANTED TO MAKE SURE THE DEVICE WAS WORKING APPROPRIATELY AND THERE WAS NO OTHER TROUBLESHOOTING THEY SHOULD DO. CONFIRMED THEY WOULD RECOMMEND VERIFYING THE PROBE PLACEMENT AND CHECKING IF IT CORRELATES WITH ANOTHER TEMPERATURE. THEY ALSO RECOMMEND CHANGING OUT THE PROBE IF UNSURE IT WAS ACCURATE. INFORMED NURSE DID SEE LESS LAG TIME WITH ESOPHAGEAL PROBES, WHICH MIGHT BE WHY IT WAS HIGHER THAN THE RECTAL TEMPERATURE. THE READINGS COULD BE DIFFERENT DEPENDING ON MODALITY AND PLACEMENT. DISCUSSED LOWER WATER LIMIT (LWL) AND CONFIRMED IT WAS 10C. IF THE PATIENT WAS SHIVERING AND GENERATING HEAT, THEN THE PATIENTS CORE TEMPERATURE MIGHT TRULY BE ABOVE TARGET, AND THE DEVICE WOULD CONTINUE MAKING COLD WATER TO TRY TO GET THE PATIENT DOWN TO TARGET. NURSE WOULD CONTINUE TO MONITOR AND CALL BACK IF NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2371438 | UNKNOWN ARCTIC SUN 5000 | ARCTIC SUN DEVICE | DWJ | MEDIVANCE, INC. ¿ 1725056 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |