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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC GEL PAD Back to Search Results
Catalog Number 318-02
Device Problems Device Alarm System (1012); 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 device was not returned.
 
Event Description
It was reported that there was low flow. The flow was 1. 0lpm on a neonate. The device was alerting and there was a low flow flag under the flow rate. The nurse rebooted device to get rid of alarming.
 
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Brand NameARCTICSUN GEL PADS
Type of DeviceARCTIC 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 Key10084085
MDR Text Key192164189
Report Number1018233-2020-03338
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2020
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 Received06/10/2020
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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