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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Device Alarm System (1012); Insufficient Cooling (1130)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the nurse had gone through three arctic sun devices. The patient was not currently on a device, and they switched to stryker cooling blankets and ice packs and were wondering about getting a loaner device. The first arctic sun device was alarmed and advised to take the device out of the service. It was also reported that the first arctic sun device switched out to a second device that worked fine all night, but then after ct (computed tomography) scan the device was not cooling, so it was switched out and the complainant just took off the third device because the water temperature was going up instead of going down to cool the patient. The patient temperature was 98. 6 f. The complainant had tried adding the water and other troubleshooting method¿s, but nothing seemed to work. Ms&s advised the nurse since the device was not in use, it would be difficult to troubleshoot and asked to send the devices to biomed for further investigation. Ms&s also explained that adding water to the device should not be a part of troubleshooting as this could lead to a malfunctioning of the heater. They called earlier on the same day and stated that the second device was not cooling and received an alert 113. The patient was currently 34. 7 c and the water temperature was 37 c. The water temperature was 88. 1 f (31. 2 c). The target temperature was 91 f (32. 3 c). The patient temperature was 96 f (35. 6 c). There was a good flow. There were multiple alerts of 113. It was noted that nothing was blocked in the vents and mo other devices were available in the ccu (critical care unit) or nicu (neonatal intensive care unit).
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key11263523
MDR Text Key229812490
Report Number1018233-2021-00222
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 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
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 Received08/10/2021
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

Patient Treatment Data
Date Received: 02/01/2021 Patient Sequence Number: 1
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