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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 318-02
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation. A failure mode of '3. 2 air leakage into the system¿ with a root cause of '3. 2. 1 misconnection of supply and return lines. ¿ the lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: "if the pad fails to prime or a significant continuous air leak is observed in the pad return line, check the connections, then if needed, replace the leaking pad. Once the pad is primes, assure the steady state flow rate displayed on the control panel is appropriate. The minimum flow rate should be 1. 1 l/m".
 
Event Description
It was reported that the arctic sun device displayed a low air leak message. The pads were disconnected and reconnected. The flow rate increased to 3. 1 lpm.
 
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Brand NameARCTICSUN GEL PADS
Type of DeviceARCTIC SUN 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 Key9126165
MDR Text Key188849627
Report Number1018233-2019-06007
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
Report Date 09/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number318-02
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 Received09/06/2019
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

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