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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS ARCTICSUN GEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS ARCTICSUN GEL PADS Back to Search Results
Device Problems Display or Visual Feedback Problem (1184); Inaccurate Flow Rate (1249)
Patient Problems Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 the arctic sun device was displaying an extended period of cold water temp alarm. The water temperature was between 4-9c, the target temperature was 37c, and the patient temperature was 37c. The flow rate was marginal to good at 2lpm - 2. 8lpm. The patient was on dialysis, and was administered tylenol, mag, buspar and antibiotics. Per troubleshooting, it was explained that the patient's heat generation from shivering could contribute to the issue, and that the facility needed to be diligent with skin assessments. Additional information was received from the facility on the 11apr2019, that the patient was able to complete therapy with the same set of pads.
 
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Brand NameARTICGEL PADS
Type of DeviceARCTICSUN GEL PADS
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 Key8560449
MDR Text Key143414136
Report Number1018233-2019-02202
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
Type of Report Initial,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received05/07/2019
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

Patient Treatment Data
Date Received: 04/29/2019 Patient Sequence Number: 1
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