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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN 5000; SYSTEM, THERMAL REGULATING
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MEDIVANCE, INC. ARCTIC SUN 5000; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 50000000L
Device Problems Material Too Rigid or Stiff (1544); Patient Device Interaction Problem (4001)
Patient Problems Bruise/Contusion (1754); Necrosis (1971)
Event Date 03/07/2021
Event Type  malfunction  
Event Description
Newborn developed fat necrosis during therapeutic hypothermia.It is unclear if this is related to the newer artic sun devices which are being investigated and reported to medsun as applicable, or positioning.A z blanket (gel pads) is also being used during cooling and this too may be a cause.The necrotic area includes posterior neck, shoulder, back and buttocks with significant hardening and bruising/dark purple areas.It was believed that the rigidness of the foam cooling blanket, coupled with the firmness of the z foam matt caused pressure points resulting in the degree of injury noted.
 
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Brand Name
ARCTIC SUN 5000
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
MEDIVANCE, INC.
321 south taylor avenue
suite 200
louisville CO 80027
MDR Report Key11619258
MDR Text Key243989039
Report Number11619258
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000L
Device Catalogue Number50000000L
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2021
Event Location Hospital
Date Report to Manufacturer04/06/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age21 DA
Patient Weight4
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