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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 Device Alarm System (1012); Overheating of Device (1437); Device Sensing Problem (2917)
Patient Problems Cardiac Arrest (1762); Death (1802); Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688); Multiple Organ Failure (3261)
Event Date 08/12/2019
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 while receiving therapy on an arctic sun device, the patient overshot target temperature. The target temperature was 33c. The target temperature was reached, but the patient¿s temperature continued to drop and reached 30c. Therapy was initiated at 0020 on (b)(6) 2019 on a (b)(6) year-old male, after a cardiac arrest. The patient weighed (b)(6) lbs. , and four pads were used for therapy. The nurse increased the water limit on the device from 40c to 42c, but the patient¿s temperature did not increase. At 0136 on (b)(6) 2019, ms&s received a call from the facility stating that the device alerted 115 (water temperature too high for too long). Ms&s advised that this was a safety feature of the machine and not a malfunction and reminded that skin assessments should include assessing the skin under the pads. The patient was receiving epinephrine, vasopressin and levophed drips. The nurse reported severe acidosis despite receiving a sodium bicarbonate drip. The physician discussed the patient¿s status with the family, and they decided to withdraw care. The patient expired immediately upon removal of the ventilator at 0941 on (b)(6) 2019. The nurse stated the cause of death was due to the patient¿s condition and not device related. The cause of death was multi-system failure. The patient had been admitted to the hospital with a diagnosis of heat exhaustion two days prior to the cardiac arrest. His medical history included congestive heart failure, chronic obstructive pulmonary disease, diabetes, coronary artery disease, oxygen dependent with tracheostomy, gastro-esophageal reflux disease, hypertension, hyperlipidemia, prostate cancer and neurogenic bladder. Surgical history included multiple orthopedic surgery and mechanical aortic valve replacement.
 
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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 Key8959559
MDR Text Key219854535
Report Number1018233-2019-05314
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 09/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
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 Received09/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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