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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTIC GEL PADS Back to Search Results
Device Problems Product Quality Problem (1506); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2021
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 had flow rate issues fluctuating from 0. 6 lpm to 1. 1 lpm in normothermia phase of therapy and noted that large arctic gel pads were in place. The initial inlet pressure (ip) was -3. 7psi, circulation pump command (cpc) was 100 percentage. Pads were connected using proper technique and now the flow rate was 1. 3lpm, initial inlet pressure (ip) was -3. 5psi and circulation pump command (cpc) was 100 percentage. The nurse noticed two pads with a lot of bubbles and one where the blue foam tubing seemed pulled away from the clear connector. The nurse stopped therapy, restarted it and now flow rate was at 2. 4lpm, initial inlet pressure (ip) was -7. 2psi, circulation pump command (cpc) was 57 percentage. Nurse stated that if flow rate issues were unresolved, would grab another machine and see if the pads work on it. Also, the nurse stated that they would call the doctor and see if they could go ahead to end therapy and send the device to the biomed. System hours were 3488.
 
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Brand NameUNKNOWN ARCTIC GEL PADS
Type of DeviceUNKNOWN ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key12715098
MDR Text Key279659804
Report Number1018233-2021-06774
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,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
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
Date Manufacturer Received12/16/2021
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: 10/28/2021 Patient Sequence Number: 1
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