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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS UNKNOWN ARCTIC GEL PAD Back to Search Results
Catalog Number UNKNOWN
Device Problems Insufficient Cooling (1130); Insufficient Flow or Under Infusion (2182); Gas Leak (2946)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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 patient was not cooling on the arctic sun device. The target temperature was 98. 6f (37c), the patient temperature was 99. 4f (37. 5c), the water temperature was 42f (5. 6c), the flow rate was 1. 2l/min. The arctic sun device was displaying 'low air leak' and an alert 02 (low flow) intermittently. System diagnostics showed flow rate was 1. 2l/min, the inlet pressure was -7 and the circulation pump command was 48%. Ms&s had nurse check the arctic gel pad tubing for bends or kinks and emptied and disconnected the arctic gel pads. They enabled manual control and set water to 10c. With no arctic gel pads attached, flow rate was 1. 8l/min, the inlet pressure was -6. 8 and the circulation pump command was 68%. They added back arctic gel pads sequentially and the results were as followed. With left thigh pad added, the flow rate was 0. 7l/min, the inlet pressure was -7. 2 and the circulation pump was 40%. With right thigh pad added, the flow rate was 1. 1l/min, the inlet pressure was -7. 3 and the circulation pump command was 47%. With right chest pad added, the flow rate was 1. 8l/min, the inlet pressure was -7. 1 and the circulation pump command was 61. With left chest pad added, the flow rate was 2. 5l/min, the inlet pressure was -7. 1 and the circulation pump command was 61%. They disabled manual and restarted therapy, the flow rate settled at 1. 9l/min and the patient was shivering. Bair hugger was in place for counter warming. The nurse stated they would give shivering medication. Ms&s acceptable flow rates.
 
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Brand NameUNKNOWN ARCTICGEL PADS
Type of DeviceUNKNOWN ARCTIC 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 Key10588539
MDR Text Key222822187
Report Number1018233-2020-06217
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
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 Received01/04/2021
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

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