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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Insufficient Heating (1287); Inappropriate or Unexpected Reset (2959)
Patient Problems Cardiac Arrest (1762); Death (1802); Brain Injury (2219); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 would continuously revert to the normothermia screen when trying to select hypothermia. The nurse noted that the water was warm, but the patient's temperature was not rising with therapy. The patient was admitted to the micu on (b)(6) 2019 post cardiac arrest. The patient was an (b)(6) female with a weight of (b)(6) and a history of interstitial lung disease and stage iv chronic copd with home oxygen. After therapy was initiated, the patient's temperature was 34. 5c and the water temperature was 37c. The flow rate was 2. 7lpm and the high water limit was 42c. The device would continuously revert to the normothermia screen when trying to select hypothermia. Nurse pam called ms&s for assistance with software issues and reaching target temperature. Ms&s recommended she cover the patient's hands, feet, and add an additional blanket for warmth. Ms&s advised that medications and patient factors can cause a patient to have difficulty rewarming. Nurse pam reported that the patient was receiving vasopressors, in addition to fentanyl and propofol which were part of the hospital's ttm protocol to prevent shivering. A follow-up call was placed the next day. Therapy had been changed from normothermia to hypothermia and 10 additional hours of cooling had been added. The complainant noted that the target temperature had been lowered to 35c to help the patient reach the target temperature more quickly. Therapy was completed on (b)(6) 2019. A call was received on 18 sept 2019, where additional information was provided that the patient expired on (b)(6) 2019 after therapy was completed on (b)(6) 2019. The nurse stated that the cause of death was due to the patient¿s condition and was not device related. The cause of death was anoxic brain injury due to cardiac arrest.
 
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Brand NameARCTICSUN 5000
Type of DeviceARCTIC SUN DEVICE
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 Key9153461
MDR Text Key166751131
Report Number1018233-2019-06207
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
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 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
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 Received10/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/03/2019 Patient Sequence Number: 1
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