• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Use of Device Problem (1670); Device Sensing Problem (2917)
Patient Problems Cardiac Arrest (1762); Death (1802); Overdose (1988); No Consequences Or Impact To Patient (2199); Cardiogenic Shock (2262); Respiratory Failure (2484)
Event Date 07/15/2020
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 on (b)(6) 2020 at 1830 that a (b)(6) year-old male patient was insufficiently maintaining temperature during the normothermia phase of therapy on an arctic sun device, sn (b)(4). The target temperature was 37c and the patient¿s temperature was 35. 3c. The nurse stopped therapy and phoned ms&s for assistance. Ms&s confirmed that the flow rate was good while therapy was running. Ms&s advised the nurse to resume therapy and adjust the rewarm rate from 0. 25c/hr to 0. 5c/hr. The flow rate at that time was 2. 1 l/min and the water temperature was 22. 7c. Ms&s phoned the nurse an hour later and the patient was at 35. 4c. The nurse asked if she could change the settings to hypothermia. Ms&s advised the nurse on how to change the cool target temperature to the patient¿s current temperature of 35. 4c. The rewarm rate was left at the default setting of 0. 25c/hr. Ms&s called back an hour later and the patient was still at 35. 4c. Warm blankets had been added and the ventilator warmer turned on. The water temperature was at 35. 4c. A follow-up phone call was placed to the icu on 16jul2020 and the day shift nurse advised the patient had expired. Additional information was received from the charge nurse on 16jul2020 via a phone call. The patient was admitted to the intensive care unit on (b)(6) 2020 from the emergency department (ed), with a diagnosis of malignant hyperthermia. The patient had presented to the ed with a suspected drug overdose. His initial body temperature was 41. 8c and cooling therapy was initiated in the ed after the patient had a respiratory arrest. The patient expired on 16jul2020 at 0722. The charge nurse stated the cause of death listed in the medical record was cardiac arrest, cardiogenic shock, overdose of unknown substance, and acute respiratory failure and was not related to the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN 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 Key10378579
MDR Text Key203157946
Report Number1018233-2020-05019
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
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 Received09/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-