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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN 5000
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MEDIVANCE, INC. ARCTIC SUN 5000 Back to Search Results
Model Number DYCXY624
Device Problems Alarm Not Visible (1022); Defective Component (2292)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Type  Injury  
Event Description
Pt presented to (b)(6) hosp from nursing home s/p cardiac arrest; intubated on multiple pressors due to shock, per protocol post cardiac arrest targeted temperature system implemented with arctic sun.Arctic sun in place on (b)(6) 2019 at 1920.Upon removal of the arctic sun cooling pads, the pt's skin was reported "without multiple layers of skin intact," the pt's skin looked like she had second - degree burns." clinical engineering investigated the equipment, performed preventive maintenance and it produced a mixing pump failure.The mfr rep reviewed the equipment for alarms, there were no alarms noted.
 
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Brand Name
ARCTIC SUN 5000
Type of Device
ARCTIC SUN 5000
Manufacturer (Section D)
MEDIVANCE, INC.
louisville CO 80027
MDR Report Key8682643
MDR Text Key147568666
Report Number8682643
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/06/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDYCXY624
Device Lot Number48353
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/18/2019
Device Age5 MO
Event Location Hospital
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age89 YR
Patient Weight34
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