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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
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 nurse was attempting to initiate the normothermia on arctic sun device for fever control but the patient temperature was not displayed. The nurse stated that the temperature in cable and the esophageal temperature probe were replaced without resolving the issue. The target temperature was 37 c the patient temperature was 39. 5 c. The event log showed multiple alarm 14 (patient temp probe 1 out of range). The temperature in cable was in temperature port 1 however no temperature was displayed. It was enabled the temperature port two and the patient temperature was displayed. The nurse moved the temperature cable from temperature port 2 to temperature port 1 and the patient temperature was displayed. The nurse disabled the temperature port two and started the therapy flow rate was 2. 6 lpm.
 
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Brand NameARCTIC SUN® 5000
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 Key13128878
MDR Text Key285044826
Report Number1018233-2021-08654
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
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 12/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
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: 12/31/2021 Patient Sequence Number: 1
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