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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 Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
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 the arctic sun device was getting low flow alert. Initially, the inlet pressure was -0. 01 psi, system hours was 7918 and pump hours 9202. 3. The flow rate was 0lpm with the circulation pump command as 100%. Disconnected and reconnected pads using proper technique but the flow rate was 0lpm. Therapy was stopped. Arctic gel pad was emptied and disconnected then the arctic sun device placed in manual control. Fluid delivery line was in place. An inlet pressure was -7psi, the flow rate was 1. 8lpm and circulation pump command as 51%. The arctic gel pad placed back one at a time and inlet pressure stabilized to 7psi. Moved pad to another port. Inlet pressure remained -0. 03. When arctic gel pad removed, inlet pressure was -7psi and the flow rate was 2. 1lpm. Patient was being tested for covid and nurse was unsure if arctic gel pad was back for investigation.
 
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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 Key10345940
MDR Text Key203284707
Report Number1018233-2020-04851
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 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2020
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 Received09/30/2020
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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