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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC SUN GELPADS NEONATAL Back to Search Results
Catalog Number 318-02-02
Device Problems Restricted Flow rate (1248); Output below Specifications (3004)
Patient Problems Hypothermia (1915); No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2020
Event Type  Injury  
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 had low flow. The complainant reported they checked the arctic sun and there was no issue. The flow rate did not increase after multiple reconnection attempts. Once the pads were exchanged, the flow rate improved.
 
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Brand NameARCTICSUN GEL PADS
Type of DeviceARCTIC SUN GELPADS NEONATAL
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 Key9945810
MDR Text Key187705586
Report Number1018233-2020-02501
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number318-02-02
Device Lot NumberNGDY1622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/09/2020 Patient Sequence Number: 1
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