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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 5000
Device Problems Display or Visual Feedback Problem (1184); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Date 09/12/2022
Event Type  malfunction  
Event Description
Arctic sun therapy was initiated in the early am.Water temperature appeared at a high value (~85f) without a warning.Icu charge nurse called to bedside for assistance.Device was troubleshooted from help menu.Soon after, emergency help line number called.Upon receiving a call-back from the helpline, troubleshooting was conducted per instruction.Error code 113 appeared & it was discovered that the device was malfunctioning.Device was stopped immediately.The device was replaced, and cooling was reinitiated a little over an hour later.
 
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Brand Name
ARCTIC SUN® 5000
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
MEDIVANCE, INC.
8195 industrial blvd
covington GA 30014
MDR Report Key16378199
MDR Text Key309561573
Report Number16378199
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 02/02/2023,10/18/2022
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 Other
Device Model Number5000
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/02/2023
Event Location Hospital
Date Report to Manufacturer02/15/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/15/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age17155 DA
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