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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE UNKNOWN TEMPERATURE CABLE Back to Search Results
Catalog Number UNKNOWN
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Temperature Problem (3022)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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 arctic sun device was not cooling the patient. The goal was 33c. The current temperature was 37c and received an alert 114, the treatment was stopped. The flow was good. The temperature t1 was 37. 1c, temperature t4 was 3. 3c. Mss advised that it seems to be a pump issue and will need to be serviced. Another device had given a power loss error yesterday and would not read the rectal probe. And tried to restart the device and changed the cable from the first device. It works well. And set aside the cable from the second device in the manager's office.
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of DeviceUNKNOWN TEMPERATURE CABLE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key10502141
MDR Text Key207115662
Report Number1018233-2020-05741
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2020
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 Received03/08/2021
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

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