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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 Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2022
Event Type  malfunction  
Event Description
It was reported that the nurse was using arctic sun device to cool patient.Device was plugged into the bed.Nurse went to check temperatures for charting and when tried to restart therapy the screen went blank, made a loud beeping noise and sounded like it was running.Unplugged and plugged into the wall outlet.Restarted therapy, stopped therapy shortly after that to document and device powered off again with blank screen, but sounded like it was on.Device was on now with no additional issues, but did alert that there was only enough water for one patient.Nurse wanted to know if they should continue using.Mis explained the initial power loss was likely due to the device being plugged into the bed.However since it has done it again since being plugged into the wall and they have another device available for use, it would not be a bad idea to send to biomed to have it evaluated.Noted that alert regarding water level was likely due to the pads no being emptied when the device powered off.Nurse was in office and did not have serial number available.Mis advised biomed could call the same number tomorrow if assistance needed from engineering.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Manufacturer Narrative
Upon further review, bd has determined that this mdr is not reportable.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: the device was not returned.
 
Event Description
It was reported that the nurse was using arctic sun device to cool patient.Device was plugged into the bed.Nurse went to check temperatures for charting and when tried to restart therapy the screen went blank, made a loud beeping noise and sounded like it was running.Unplugged and plugged into the wall outlet.Restarted therapy, stopped therapy shortly after that to document and device powered off again with blank screen, but sounded like it was on.Device was on now with no additional issues, but did alert that there was only enough water for one patient.Nurse wanted to know if they should continue using.Mis explained the initial power loss was likely due to the device being plugged into the bed.However since it has done it again since being plugged into the wall and they have another device available for use, it would not be a bad idea to send to biomed to have it evaluated.Noted that alert regarding water level was likely due to the pads no being emptied when the device powered off.Nurse was in office and did not have serial number available.Mis advised biomed could call the same number tomorrow if assistance needed from engineering.
 
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Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC 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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15939354
MDR Text Key307954446
Report Number1018233-2022-09390
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 Physician
Type of Report Initial,Followup
Report Date 04/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2022
Initial Date FDA Received12/08/2022
Supplement Dates Manufacturer Received04/06/2023
Supplement Dates FDA Received04/07/2023
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 Sequence Number1
Patient Outcome(s) Other;
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