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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS Back to Search Results
Device Problem Loss of or Failure to Bond (1068)
Patient Problem 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 the arctic sun device displayed 0 flow. There were only three pads in use because the fourth pad would not stick. The nurse disconnected and reconnected the pads using the proper technique and flow remained at 0lpm. The nurse took off the fluid delivery line and ran diagnostics. The flow rate was 2. 2lpm, and inlet pressure was -9psi range. The circulation pump was at 70%. The nurse reconnected the pads one by one and the flow dropped to 0. 0 again. Ms&s advised the nurse to change pads. Per follow up call, the patient was able to complete therapy once the pads were changed.
 
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Brand NameARCTICSUN GEL PADS
Type of DeviceGEL 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 Key9595614
MDR Text Key179482440
Report Number1018233-2020-00331
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 other,user facility
Reporter Occupation
Type of Report Initial
Report Date 01/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received12/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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