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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 Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  malfunction  
Event Description
It was reported that during maintenance the chiller temperature (t4) did not cool down on the arctic sun device.The device was under investigation for the cause and the time was unknown.The device would be evaluated at the imi facility on 25mar2022.Per follow up information received via email on 25mar2022, the device would be evaluated at the imi facility.It was not used on the patient.This issue was confirmed during an operational check by hospital personnel.
 
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 during maintenance the chiller temperature (t4) did not cool down on the arctic sun device.The device was under investigation for the cause and the time was unknown.The device would be evaluated at the imi facility on 25mar2022.Per follow up information received via email on 25mar2022, the device would be evaluated at the imi facility.It was not used on the patient.This issue was confirmed during an operational check by hospital personnel.Per sample evaluation result received on 15jun2022, the water injection tube was clogged and replaced the water injection tube.
 
Manufacturer Narrative
The reported issue was unconfirmed.The root cause was not able to be isolated as the reported issue was duplicated during evaluation.The device was evaluated and the reported issue was not able to be confirmed as the issue was not duplicated during testing.No repairs for the reported issue were made.The water injection tube is clogged.Replaced the water injection tube.Device underwent calibration and functional check.Arctic sun passed all tests successfully and unit is ready to be returned to the customer.The device history record review was not required as the reported issue was unconfirmed and not a manufacturing or supplier related failure.Labeling review was not required as the reported event is unconfirmed, h11:section a through f - the information provided by bd represents all of 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.
 
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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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14142977
MDR Text Key289523349
Report Number1018233-2022-02701
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
Combination Product (y/n)N
Reporter Country CodeJA
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 09/19/2022
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? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2022
Initial Date FDA Received04/19/2022
Supplement Dates Manufacturer Received09/20/2022
Supplement Dates FDA Received09/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2011
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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