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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS ARCTIC SUN GEL PAD Back to Search Results
Catalog Number 318-02-02
Device Problems Display or Visual Feedback Problem (1184); Gas Leak (2946); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2019
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 gel pads displayed a flow rate of 0. 2-0. 6 lpm. The pads were switched from neonatal to a small universal pad and the flow rate was optimal. Per follow up, the patient was able to reach the target temperature and complete therapy with the universal small pad.
 
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Brand NameARCTICGEL PADS
Type of DeviceARCTIC SUN 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 Key8735506
MDR Text Key149341141
Report Number1018233-2019-03376
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number318-02-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2019
Was Device Evaluated by Manufacturer? Yes
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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