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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE -1725056 ARTIC SUN MODEL 2000 TEMPERATURE MANAGEMENT SYSTEM ARCTIC SUN DEVICE

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MEDIVANCE -1725056 ARTIC SUN MODEL 2000 TEMPERATURE MANAGEMENT SYSTEM ARCTIC SUN DEVICE Back to Search Results
Catalog Number 2000-02
Device Problems Operating System Becomes Nonfunctional (2996); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 received an alarm 47 (control panel communication). The complainant powered the device off, tightened the connections and restart, but this did not resolve the issue. The patient was switched to a second device. This device was sent to the biomed. As per follow up information, nurse (b)(6) who confirmed patient had been switched to a second device to complete therapy and first device went to the biomed and they left a voicemail requesting additional information.
 
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Brand NameARTIC SUN MODEL 2000 TEMPERATURE MANAGEMENT SYSTEM
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE -1725056
321 south taylor ave
suite 200
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 Key10304974
MDR Text Key200604562
Report Number1018233-2020-04661
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071341
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 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2000-02
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 Received01/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2008
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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