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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS ARCTICSUN GEL PADS Back to Search Results
Device Problems Inaccurate Flow Rate (1249); Use of Device Problem (1670); Gas Leak (2946)
Patient Problem Underdose (2542)
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 displayed an inaccurate flow rate of 2-2. 3 l/min. The patient was given medication for myoclonic movements. One pad was changed before calling mss. Mss attempted to get flow rate up by disconnecting and reconnecting the pads and the fluid delivery line. The flow increased to 3. 6 l/min and then air leaked down to 2. 3-2. 5 l/min. The device was restarted and displayed similar numbers. Mss advised that it may be a patient issue since having some myoclonic movements. Nurse stated there was a lot of air bubbling in the pads. Mss advised nurse to continue therapy and call back if the machine stops.
 
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Brand NameUNKNOWN ARCTICGEL PADS
Type of DeviceARCTICSUN GEL PADS
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 Key8497378
MDR Text Key141432198
Report Number1018233-2019-01793
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
Report Date 05/29/2019
1 Device was Involved in the Event
2 Patients were Involved in the Event: 1   2  
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
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 Received04/18/2019
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

Patient Treatment Data
Date Received: 04/09/2019 Patient Sequence Number: 0
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