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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 Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2022
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 arctic sun device would not fill. A check of the diagnostics showed that the circulation pump would not generate pressure more than -0. 5psi. The customer requested a quote for the 2000 hours service and a loaner. Per follow up information received on 29jul2022, there was no patient involvement reported. A quote has been sent to customer and they would determine if they would send device in for service. Per sample evaluation results received on 16aug2022, it was confirmed that during decontamination the unit would not autofill unless the circulation pump was first primed. The root cause was determined to be a failed circulation pump. There was physical damage to the front of the i/o circuit card. The damage did not appear to affect the operation of the i/o circuit card during testing. Pt1 (patient temperature measurement) connection on the isolation circuit card had been pushed through the front of the card damaging the solder connections to the circuit card. The hot and return connection on the fourth element of the heater was found during decontamination to be shorted to chassis causing breaker resets. The heater was removed from the electronics to complete all testing.
 
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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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15302689
MDR Text Key303557251
Report Number1018233-2022-06683
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
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2022
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2022
Was Device Evaluated by Manufacturer? No
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: 08/26/2022 Patient Sequence Number: 1
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