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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN GEL PADS ARCTIC GEL PAD Back to Search Results
Catalog Number 317-07-02
Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2020
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 during the ttm treatment, arctic sun device flow rate was decreased with low flow alarms. Customer did empty pads several times, reconnected all four pads and checked any leakage from pads. After all the customer's effort, they changed other gel pads and the flow rate was maintained as 1. 8~1. 9l/min. Arctic gel pad was replaced for patient.
 
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Brand NameARCTIC SUN 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 Key10321550
MDR Text Key201358829
Report Number1018233-2020-04760
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Catalogue Number317-07-02
Device Lot NumberNGDZ3069
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2020
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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