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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 317-09-02
Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); Shaking/Tremors (2515)
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 patient was not cooling on the arctic sun device. Nurse called stating she received an alert about patient or water temperature. The device received alert 52 (extended period of cold water). Ms&s explained that it was a safety alert and they should be conducting regular skin checks to ensure patient safety. Nurse confirmed she has been doing regular skin checks. They also noted that an alarm 53 (prolonged cold water exposure). Ms&s stated this will start after they receive an alert 52(extended period of cold water) 11 times. Those alarms would stop therapy so the nurse will need to press start after an alarm. Patient weighed (b)(6) kg with size large pads. Nurse denied any exposed skin. Patient was 39. 2, target was 37c, water was c6. 4c, and flow rate was 1. 2 l/m. Nurse confirmed all pads were connected and lines were straight with no kinks. Ms&s discussed disconnecting and reconnecting to increase flow. Patient was shivering and a bair hugger was applied. Patient was receiving fentanyl, sedation, buspirone, and tylenol but was still experiencing mild shivering. Discussed consulting physician for additional treatment of shivering. Noted that as long as patient is generating heat, the water will remain cold to try to bring down the patient's temp. Nurse will call back if additional questions.
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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
MDR Report Key10348681
MDR Text Key202475664
Report Number1018233-2020-04883
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-09-02
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 Received10/07/2020
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