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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS Back to Search Results
Catalog Number 317-05-02
Device Problems Insufficient Flow or Under Infusion (2182); Gas Leak (2946)
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. ¿.
 
Event Description
It was reported that the arctic sun device showed low flow. The patient temperature was 35. 9c, target temperature was 33, water temperature 6. 9, flow rate 0. 7lpm when small pads were used. Initial inlet pressure was -3psi, system hours 838, pump hours 655. When the complainant disconnected and reconnected pads using proper technique and the fluid rate was 2. 3lpm but it dropped later and alerted low air leak ( alert 02 ) again. The therapy was stopped and the pads were disconnected or emptied. When placed in manual control, just fluid delivery line, the flow rate was 1. 8lpm, inlet pressure -7psi, circulation pump 55%. The right chest pad had a flow rate of 2. 1lpm, inlet pressure -2. 3psi and circulation pump 100. Manual control was disabled. Therapy was continued. The nurse stated that the set of pads would be changed and call if needed.
 
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Brand NameARCTIC GEL PADS
Type of DeviceARCTIC 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 Key10092856
MDR Text Key193701248
Report Number1018233-2020-03430
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 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-05-02
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 Received06/21/2020
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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