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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN SYSTEM, THERMAL REGULATING

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MEDIVANCE, INC. ARCTIC SUN SYSTEM, THERMAL REGULATING Back to Search Results
Device Problems Insufficient Flow or Under Infusion (2182); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 07/08/2021
Event Type  malfunction  
Event Description
Attempted to initiate arctic sun. Unable to start therapy in a timely manner. Machine alarming low flow. Attempted to trouble shoot, used all trouble shooting techniques taught to get machine to run. Machine would not run. Called trouble shooting number provided, no answer. Looked up another number for the company and no answer. Initiating therapy was delayed due to machine not working properly. Had to obtain another machine from a different unit which did work and therapy initiated 20 minutes later. It does not appear harm came to the patient as a result of equipment failure.
 
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Brand NameARCTIC SUN
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
MEDIVANCE, INC.
321 south taylor avenue
suite 200
louisville CO 80027
MDR Report Key12391443
MDR Text Key268940157
Report Number12391443
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 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2021
Event Location Hospital
Date Report to Manufacturer08/31/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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