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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the arctic sun device continued to alarm that the water temperature was too cold. Patient temperature was 38c and target temperature was 37c. Therapy was currently stopped. The alarm was bothering the family and patient wanted to know if they could turn it off. Alert 52 (extended period of cold water) and alarm 53 (prolonged cold-water exposure) was confirmed. It was also reported that the circulating water temperature had been below 10°c (50°f) for 8 of the previous 10 hours. Mss advised that alarm 52 would recur after 1 hour if the condition continued. After the device had issued 11 extended cold water exposure alarms, it would issue a prolonged cold water exposure alarm, alarm 53 which would stop therapy as a safety feature. Extended periods of cold water delivery might increase the risk for skin injury. Mss advised the complainant to assess patients¿ skin underneath the arctic gel pads and stated that if skin looked normal, then therapy could be resumed. This alarm could not be disabled. Mss suggested addressing heat generation per facility protocol and adding counter warming and chilled saline.
 
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Brand NameARCTIC SUN DEVICE
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13172240
MDR Text Key283296520
Report Number1018233-2021-08704
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60000000
Device Catalogue Number60000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
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