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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-05
Device Problems Display or Visual Feedback Problem (1184); Inaccurate Flow Rate (1249)
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 information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that the arcticsun device was displaying low flow alert 02. The patient temperature was 36. 5c and the target temperature was 36c. The device was switched and the alert returned. Per troubleshooting the pads were disconnected and reconnected using proper technique with no change in flow. Took off fdl and ran diagnostics, then reconnected pads one by one and flow dropped again. They were advised to switch out pads. Per additional information received on (b)(6) 2019, the patient was able to complete therapy on the second set of pads.
 
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Brand NameARCTICGEL 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 Key8449788
MDR Text Key139819987
Report Number1018233-2019-01517
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 07/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue Number317-05
Device Lot NumberNGCW2185
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2018
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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