ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Report
- Report Number
- 1018233-2025-05850
- Event Type
- Malfunction
- Date Received
- July 15, 2025
- Date of Event
- July 9, 2025
- Report Date
- September 30, 2025
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- PMA / PMN Number
- K142702
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. THE INITIAL REPORTER FACILITY NAME PROVIDED IS SUTTER HEALTH - (B)(6). CORRECTION: B, D. 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 INITIAL REPORTER FACILITY NAME PROVIDED IS SUTTER HEALTH - (B)(6) HOSPITAL. 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.
THE REPORTED EVENT IS CONFIRMED CAUSE UNKNOWN AS THEY CHANGED THE PADS AND AIR LEAK ISSUE IS SOLVED. SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THIS OCCURRENCE DOES NOT INTRODUCE A NEW HAZARD OR HARM. IT REPRESENTS A KNOWN FAILURE MODE THAT HAS BEEN ASSESSED IN THE PRODUCT RISK MANAGEMENT FILE IN ACCORDANCE WITH APPLICABLE REGULATORY STANDARDS AND INTERNAL PROCEDURES. THE ASSOCIATED RISKS CONTINUE TO BE MONITORED AS PART OF ONGOING POST-MARKET ACTIVITIES IN COMPLIANCE WITH BOTH REGULATORY REQUIREMENTS AND LOCAL PROCEDURES. THE LABELING IS FOUND TO BE ADEQUATE. THE BAW IS ATTACHED TO THE INVESTIGATION OVERVIEW ELEMENT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. CORRECTION: D. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 ANSWERING PHONE STATED THEY FIGURED IT OUT. NURSE STATED THAT THEY WERE TRYING TO START THERAPY BUT KEPT GETTING LOW FLOW AND AIR LEAK ALERT IN AN ARCTIC SUN DEVICE. THEY MOVED TO A DIFFERENT MACHINE AND GOT THE SAME MESSAGE, SO THEY PUT ON A NEW SET OF PADS AND NOW HAVE A GOOD FLOW RATE. ENCOURAGED THEM TO CALL NEXT TIME BEFORE SWAPPING OUT PADS. CUSTOMER STATED THEY RESOLVED. PER ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE ARCTIC GEL PAD WAS TRIGGERING LOW FLOW ALARM ON ARCTIC SUN DEVICE. NEW SET OF PADS RESOLVED THE ISSUE. TRIED FAULTY PADS ON ANOTHER DEVICE AND THE SAME ALARM WAS TRIGGERED.
IT WAS REPORTED THAT THE NURSE ANSWERING PHONE STATED THEY FIGURED IT OUT. NURSE STATED THAT THEY WERE TRYING TO START THERAPY BUT KEPT GETTING LOW FLOW AND AIR LEAK ALERT IN AN ARCTIC SUN DEVICE. THEY MOVED TO A DIFFERENT MACHINE AND GOT THE SAME MESSAGE, SO THEY PUT ON A NEW SET OF PADS AND NOW HAVE A GOOD FLOW RATE. ENCOURAGED THEM TO CALL NEXT TIME BEFORE SWAPPING OUT PADS. CUSTOMER STATED THEY RESOLVED.
IT WAS REPORTED THAT THE NURSE ANSWERING PHONE STATED THEY FIGURED IT OUT. NURSE STATED THAT THEY WERE TRYING TO START THERAPY BUT KEPT GETTING LOW FLOW AND AIR LEAK ALERT IN AN ARCTIC SUN DEVICE. THEY MOVED TO A DIFFERENT MACHINE AND GOT THE SAME MESSAGE, SO THEY PUT ON A NEW SET OF PADS AND NOW HAVE A GOOD FLOW RATE. ENCOURAGED THEM TO CALL NEXT TIME BEFORE SWAPPING OUT PADS. CUSTOMER STATED THEY RESOLVED. PER ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE ARCTIC GEL PAD WAS TRIGGERING LOW FLOW ALARM ON ARCTIC SUN DEVICE. NEW SET OF PADS RESOLVED THE ISSUE. TRIED FAULTY PADS ON ANOTHER DEVICE AND THE SAME ALARM WAS TRIGGERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1535348 | ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS | ARCTIC GEL PADS | DWJ | MEDIVANCE, INC. ¿ 1725056 | NGKQ0133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |