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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS ARCTIC GEL PADS Back to Search Results
Device Problems Device Alarm System (1012); Restricted Flow rate (1248)
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. The device was not returned.
 
Event Description
It was reported that the arctic sun device was getting a low flow alarm. The nurse switched out the device, but was still getting a low flow alarm. The flow rate was 0. 0l/min. Per troubleshooting with ms&s, the nurse disconnected and reconnected the pads using proper technique. There was no change in flow. The nurse ran diagnostics, and the flow rate was in the 2l/min range with -8psi inlet pressure, and the circulation pump command was in the 50% range. The nurse reconnected the pads one by one, and the device was still showing low flow. The nurse stated the patient was on the larger side, and ms&s recommended checking the pads under the patient to ensure they were flat. Per follow up with nurse via phone on (b)(6) 2020, the pads were replaced for the patient to continue therapy.
 
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Brand NameUNKNOWN ARCTICGEL PADS
Type of DeviceARCTIC 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 Key10038221
MDR Text Key191255292
Report Number1018233-2020-03091
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 05/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2020
Is this an Adverse Event Report? No
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 Received05/15/2020
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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