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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE MEDIVANCE ARCTIC SUN HYPOTHERMIA MACHINE

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MEDIVANCE MEDIVANCE ARCTIC SUN HYPOTHERMIA MACHINE Back to Search Results
Model Number 300148
Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 03/18/2017
Event Type  malfunction  
Event Description
Patient was a post cardiac arrest receiving hypothermia via arctic sun protocol. During the maintenance process the machine was alarming and giving an error message 74. The medivance representative was called and tried to provide troubleshooting and it was determined that there was a software issue with the arctic sun.
 
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Brand NameMEDIVANCE
Type of DeviceARCTIC SUN HYPOTHERMIA MACHINE
Manufacturer (Section D)
MEDIVANCE
louisville CO 80027
MDR Report Key6450716
MDR Text Key71528452
Report NumberMW5068807
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number300148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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