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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 PAD

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC SUN GEL PAD Back to Search Results
Catalog Number 317-00
Device Problems Use of Device Problem (1670); Gas Leak (2946); Infusion or Flow Problem (2964)
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 there was a low air leak and low flow on the arctic sun device. The patient temperature was 38c with a target temperature of 36. 5c. The flow rate was 1. 1l/min, and the water temperature was 5. 6c but the nurse stated the pads did not feel cold on the patient. Per troubleshooting with ms&s, the nurse stated that the patient only had two universal pads on because the unit did not have a full set of pads available. The nurse was advised to locate a full set of pads to properly deliver therapy. The nurse stated she would check in another unit or neighboring hospitals for a full set of pads. Per follow up with nurse (b)(6) via phone on 22jul2019, the patient was continuing therapy successfully with no further issues with a new set of pads.
 
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Brand NameARCTICSUN GEL PADS
Type of DeviceARCTIC SUN GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
321 s taylor ave
louisville, CO 80027
7707846100
MDR Report Key8884259
MDR Text Key184694547
Report Number1018233-2019-04654
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,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-00
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 Received08/28/2019
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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