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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problem Computer Operating System Problem (2898)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
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 hyperthermia patient was cooling on arctic sun stat device since yesterday. The nurse stated that the device sounded an alarm 80 (non-recoverable system error), the control processor failed to detect a simulated water temperature fault. Mss told nurse to turn the control module off and to wait for 30 seconds and to turn control module on. Mss insisted to send the device to biomedical engineering department for further investigation if alarm reoccurred.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM
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 Key12973752
MDR Text Key282037302
Report Number1018233-2021-07906
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 11/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
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 Received11/22/2021
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: 12/09/2021 Patient Sequence Number: 1
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