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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 50000000
Device Problems Use of Device Problem (1670); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2021
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 normothermia patient was on the arctic sun device with a target of 37c. The device alarmed and powered off. The device alerted that it needed water so sterile saline was added and the device took less than 1 liter. Nurse just realized that they should have added sterile water and not sterile saline. The patient temperature was 35. 9c, water temperature was 24. 1c and flow rate was 3lpm. The event log showed an alert 45 (ac power lost), one alert 05 (water reservoir empty) and there were no other alarms or alerts. The device was plugged into the bed and mss explained that the device must be plugged into a wall outlet and not the bed. The pads were not emptied before water was added and they drained 500 ml from the right drain port. Now the water temperature was rising and mss explained that the device was overfilled as pads were not emptied before water was added. Mss recommended the nurse to contact the biomedical engineering department so they can drain the device to remove the saline and fill with sterile water and cleaning solution. The water temperature was up to 40c by the end of the call and a bair hugger in place.
 
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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 Key12870582
MDR Text Key283791987
Report Number1018233-2021-07533
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
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
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
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: 11/24/2021 Patient Sequence Number: 1
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