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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS UNKNOWN ARCTIC GEL PAD

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS UNKNOWN ARCTIC GEL PAD Back to Search Results
Catalog Number UNKNOWN
Device Problems Break (1069); Display or Visual Feedback Problem (1184); Material Fragmentation (1261); Infusion or Flow Problem (2964); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that there was no flow on arctic sun device. The patient was below target temperature after 1 hour of therapy and the goal was 36c. The patient was 35c temperature and the water temperature was 28c. The user filled the reservoir when flow was zero. Event log showed alert 113 (reduced water temperature control) and alert 001 (patient line open). Ms&s had disconnected and reconnected the arctic gel pads and the fluid delivery line (fdl). One leg pad had a broken plastic piece that would not click into fluid delivery line. The user had changed it out but the flow rate was still zero. Ms&s had take off fluid delivery line but still did not feel pressure and also stated that user would change the device. There was still no flow.
 
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Brand NameUNKNOWN ARCTICGEL PADS
Type of DeviceUNKNOWN ARCTIC GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key10469669
MDR Text Key206101100
Report Number1018233-2020-05575
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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