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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS Back to Search Results
Device Problems Inaccurate Flow Rate (1249); Insufficient Heating (1287); Device Displays Incorrect Message (2591)
Patient Problems Cardiac Arrest (1762); Death (1802); No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
Event Date 05/23/2019
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 a patient was insufficiently warming while receiving therapy on the arctic sun device, sn# (b)(4), at 1758 on (b)(6) 2019. The (b)(6) year old female was placed on the arctic sun device following a cardiac arrest with suspected anoxic brain injury. During the rewarming phase, the patients¿ temperature was 31. 7c with a target temperature of 36. 5c. The water temperature was between 36c-40c, the flow rate was 1. 2l/min with five pads, and good coverage was reported. The nurse reported no alarms or alerts and the patient had stable vital signs. Through troubleshooting with the ms&s helpline, it was confirmed that there was an alert 51 (patient temperature 1 below control range, alert 115 (prolonged warm water exposure), and alert 02 (low flow). The nurse advised ms&s that the device would be switched out. During a follow-up phone call on (b)(6) 1019, the nurse reported the patient experienced a second cardiac arrest and expired on (b)(6) 2019 at 0220 on the same device. The nurse stated the cause of death was cardiac arrest and not device related. The nurse also stated the neurological condition of the patient prevented her core temperature from rewarming. The device was sent to biomed for evaluation. The patient had a history of drug abuse and was recently diagnosed with cancer and had not started any cancer treatment. She received vasopressors intermittently during her hospitalization.
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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 Key8693210
MDR Text Key148430351
Report Number1018233-2019-03100
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
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2019
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