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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problems Overfill (2404); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2021
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 a hypothermia patient was rewarming on the arctic sun device. Nurse reported that the device was sounding an alert 113 (reduced water temperature control). The patient temperature was 35. 9c, water temperature was 32. 6c, flow rate was 2. 6lpm. The reservoir level showed 5. The rewarm had switched to read normothermia and to rewarm from 37c at 0. 25c/hour to 37c. Mss walked through draining 500 ml of water from the right drain port. Then the water temperature immediately rose to 39c and changed the settings to rewarm from 36. 2c, which was the patient current temperature at 0. 25c/hour to 37c.
 
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Brand NameARCTIC SUN DEVICE
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 Key13125688
MDR Text Key284529867
Report Number1018233-2021-08631
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741161513
UDI-Public(01)00801741161513
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60000000
Device Catalogue Number60000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2021
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: 12/31/2021 Patient Sequence Number: 1
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