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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICSUN 5000 UNKNOWN ARCTIC SUN DEVICE Back to Search Results
Catalog Number UNKNOWN
Device Problems Insufficient Cooling (1130); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the patient was above target while undergoing therapy on arctic sun device. The patient temperature was 37. 8c, the target temperature was 35c, the water temperature was 31. 1c, and the flow rate was 2. 6lpm. They confirmed an alert 113 (reduced water temperature) in the event log. System hours were 7030, the pump hours were 6497, the chiller temperature (t4) was 4. 3c and the mixing pump command was 100%. Ms&s advised to stop therapy, empty pads and send device to biomed labeled mixing pump. Per follow up via nurse on 27jan2021, switched to a second device to continue therapy. Therapy was discontinued on second device. 2nd device was kept in service and 1st device was sent to biomed.
 
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Brand NameUNKNOWN ARCTICSUN 5000
Type of DeviceUNKNOWN ARCTIC 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 Key11345509
MDR Text Key233078722
Report Number1018233-2021-00651
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 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
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: 02/18/2021 Patient Sequence Number: 1
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