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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 50000000L
Device Problem Computer Operating System Problem (2898)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
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 received a reboot error and powered off the device 2 times, but the same error occurred. As the patient recently completed the rewarming procedure, they decided to remove the device. They had no other device to use. Ms&s suggested the nurse to send the device to the biomed.
 
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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 Key11008825
MDR Text Key221497069
Report Number1018233-2020-21679
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000L
Device Catalogue Number50000000L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2011
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: 12/15/2020 Patient Sequence Number: 1
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