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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
Catalog Number 50000000
Device Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2024
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 biomed has a arctic sun device that was sent down because it was unable to maintain patient temperature, several 113 (reduced water temperature control) alerts in the event log and confirmed an issue with cooling.Device would not cool during the calibration, it failed for an error 80 (water check time out - unable to reach calibration temperature)expected 6 actual 28.48.Chiller temperature (t4) was 29 degrees and had water in chiller tank.
 
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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 Key19202731
MDR Text Key341299825
Report Number1018233-2024-02372
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
Report Date 04/15/2024
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 Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/09/2024
Initial Date FDA Received04/29/2024
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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