ARCTIC SUN® 5000
Report
- Report Number
- 1018233-2025-02613
- Event Type
- Malfunction
- Date Received
- April 14, 2025
- Date of Event
- April 9, 2025
- Report Date
- May 12, 2025
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- UDI-DI
- 00801741127755
- PMA / PMN Number
- K161602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, 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. 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 ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, AS THE DEVICE FUNCTIONED APPROPRIATELY DURING EVALUATION. THEY RAN A CALIBRATION CHECK AND PASSED. A DHR REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. THE LABELING/PACKAGING REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. 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 THEY SPOKE TO BIOMED AND STATED THAT THE ARCTIC SUN DEVICE HAD RECEIVED AND ALERT 64 (NON-RECOVERABLE SYSTEM ERROR) AND 47 (CONTROL PANEL COMMUNICATION) ONE TIME EACH, THEY RAN A CALIBRATION CHECK AND PASSED. PER WO NOTES THEY HAD THE UNIT RUNNING SINCE 6 AM AND HAD NOT RECEIVED EITHER ALERT ANYMORE SO THEY WOULD BE RETURNING IT TO THE FLOOR. NURSE STATED THAT THEY HAVE A PATIENT THAT HAS BEEN COOLING SINCE 20:14 ON THE 6TH. THE DEVICE GAVE A NON-RECOVERABLE ERROR 64. NURSE REBOOTED THE DEVICE AND RESUMED THERAPY. AFTER ABOUT 10 MINUTES, IT GAVE A NON-RECOVERABLE ERROR 47. THEY HAD REBOOTED IT AGAIN AND RESUMED THERAPY FOR NOW, BUT THEY WERE BORROWING A DEVICE FROM THE ADULT UNIT TO SWAP IT OUT WITH. THEY WOULD SEND THE FIRST DEVICE TO BIOMED. NURSE ASKED HOW TO ADJUST THE ADULT PROTOCOL TO THEIR NICU PROTOCOL. NURSE SELECTED HYPOTHERMIA PROTOCOL. NURSE ADJUSTED TARGETED TEMPERATURE (TT) WAS TO 33.5C AND DURATION TO 21 HOURS TO REACH THEIR REMAINING COOLING DURATION. HAD NURSE SELECT MORE, COOLING IS SET TO BEGIN IMMEDIATELY. NURSE ADJUSTED REWARMING TO BEGIN AUTOMATICALLY. HAD NURSE ADJUST HIGH WATER LIMIT (HWL) TO 40C AND LOWER WATER LIMIT (LWL) TO 10C AND SAVE. NURSE ADJUSTED REWARMING SETTINGS TO REWARM FROM 33.5C AT A RATE OF 0.5C/HOUR TO THEIR TARGET OF 36.5C PER THEIR PROTOCOL AND SAVE. NURSE WOULD SWAP THE PAD OVER TO START THERAPY AND CALL BACK IF THEY HAD ANY ISSUES. BIOMED HAD A DEVICE THAT GAVE A NON-RECOVERABLE ALARM 64 AND THEN 47 LAST NIGHT. THEY RAN A CALIBRATION CHECK ON IT AND IT PASSED. BIOMED WANTED TO KNOW IF THEY SHOULD DO ANYTHING ELSE.
IT WAS REPORTED THAT THEY SPOKE TO BIOMED AND STATED THAT THE ARCTIC SUN DEVICE HAD RECEIVED AND ALERT 64 (NON-RECOVERABLE SYSTEM ERROR) AND 47 (CONTROL PANEL COMMUNICATION) ONE TIME EACH, THEY RAN A CALIBRATION CHECK AND PASSED. PER WO NOTES THEY HAD THE UNIT RUNNING SINCE 6 AM AND HAD NOT RECEIVED EITHER ALERT ANYMORE SO THEY WOULD BE RETURNING IT TO THE FLOOR. NURSE STATED THAT THEY HAVE A PATIENT THAT HAS BEEN COOLING SINCE 20:14 ON THE 6TH. THE DEVICE GAVE A NON-RECOVERABLE ERROR 64. NURSE REBOOTED THE DEVICE AND RESUMED THERAPY. AFTER ABOUT 10 MINUTES, IT GAVE A NON-RECOVERABLE ERROR 47. THEY HAD REBOOTED IT AGAIN AND RESUMED THERAPY FOR NOW, BUT THEY WERE BORROWING A DEVICE FROM THE ADULT UNIT TO SWAP IT OUT WITH. THEY WOULD SEND THE FIRST DEVICE TO BIOMED. NURSE ASKED HOW TO ADJUST THE ADULT PROTOCOL TO THEIR NICU PROTOCOL. NURSE SELECTED HYPOTHERMIA PROTOCOL. NURSE ADJUSTED TARGETED TEMPERATURE (TT) WAS TO 33.5C AND DURATION TO 21 HOURS TO REACH THEIR REMAINING COOLING DURATION. HAD NURSE SELECT MORE, COOLING IS SET TO BEGIN IMMEDIATELY. NURSE ADJUSTED REWARMING TO BEGIN AUTOMATICALLY. HAD NURSE ADJUST HIGH WATER LIMIT (HWL) TO 40C AND LOWER WATER LIMIT (LWL) TO 10C AND SAVE. NURSE ADJUSTED REWARMING SETTINGS TO REWARM FROM 33.5C AT A RATE OF 0.5C/HOUR TO THEIR TARGET OF 36.5C PER THEIR PROTOCOL AND SAVE. NURSE WOULD SWAP THE PAD OVER TO START THERAPY AND CALL BACK IF THEY HAD ANY ISSUES. BIOMED HAD A DEVICE THAT GAVE A NON-RECOVERABLE ALARM 64 AND THEN 47 LAST NIGHT. THEY RAN A CALIBRATION CHECK ON IT AND IT PASSED. BIOMED WANTED TO KNOW IF THEY SHOULD DO ANYTHING ELSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2378489 | ARCTIC SUN® 5000 | ARCTIC SUN DEVICE | DWJ | MEDIVANCE, INC. ¿ 1725056 | NA | 00801741127755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |