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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 Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2023
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 customer had now decided that they would like the arctic sun device repaired.Per biomed call to mis on 26jan2023, biomed needed assistance with device that turns on, but no power to screen or blank screen.Device just returned from service department.Per follow up information received via phone on 01feb2023, biomed stated that the device was coming in for repair.Per sample evaluation results received on 24feb2023, the root cause of the reported issue was due to a failed control panel.During evaluation, it was confirmed that the screen did not boot up.It was reported that the ac power cord had exposed, insulated wires, cut outer jacket and this had no effect on the operation of the unit, but would be replaced as part of the preventive maintenance.It was stated that pt1 (patient temperature measurement) on isolation circuit card was pulled forward from the printed circuit board and had fractured the solder joints on the printed circuit board.It was stated that excessive travel on the power inlet switch causing device to power off and reboot when over pressed, this had no effect on the operation of the unit but would be replaced as part of the preventive maintenance.The tank seals were worn and torn due to normal wear.The corrosion on tank mounting bolts indicates leaking tank seals.The circulation pump recorded low or marginal flow than expected using test loop.The wires leading to inlet temperature (t3) thermistor were found twisted to the point it frayed the insulation at the end of the thermistor exposing the inner wire, this had no effect on the operations of the unit but would be replaced.It was noted that the l-tube and double l-tubing appeared distended or expanded however water flow was not impeded and would be replaced as part of the preventive maintenance.It was noted that replaced corroded bolts with new bolts, isolation card and manifold harness.
 
Event Description
It was reported that customer had now decided that they would like the arctic sun device repaired.Per biomed call to mis on 26jan2023, biomed needed assistance with device that turns on, but no power to screen or blank screen.Device just returned from service department.Per follow up information received via phone on 01feb2023, biomed stated that the device was coming in for repair.Per sample evaluation results received on 24feb2023, the root cause of the reported issue was due to a failed control panel.During evaluation, it was confirmed that the screen did not boot up.It was reported that the ac power cord had exposed, insulated wires, cut outer jacket and this had no effect on the operation of the unit, but would be replaced as part of the preventive maintenance.It was stated that pt1 (patient temperature measurement) on isolation circuit card was pulled forward from the printed circuit board and had fractured the solder joints on the printed circuit board.It was stated that excessive travel on the power inlet switch causing device to power off and reboot when over pressed, this had no effect on the operation of the unit but would be replaced as part of the preventive maintenance.The tank seals were worn and torn due to normal wear.The corrosion on tank mounting bolts indicates leaking tank seals.The circulation pump recorded low or marginal flow than expected using test loop.The wires leading to inlet temperature (t3) thermistor were found twisted to the point it frayed the insulation at the end of the thermistor exposing the inner wire, this had no effect on the operations of the unit but would be replaced.It was noted that the l-tube and double l-tubing appeared distended or expanded however water flow was not impeded and would be replaced as part of the preventive maintenance.It was noted that replaced corroded bolts with new bolts, isolation card and manifold harness.
 
Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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.
 
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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 Key16565077
MDR Text Key311605177
Report Number1018233-2023-01827
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 05/02/2023
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/24/2023
Initial Date FDA Received03/17/2023
Supplement Dates Manufacturer Received04/27/2023
Supplement Dates FDA Received05/02/2023
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 Sequence Number1
Patient Outcome(s) Other;
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