MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

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.

• 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 Key: 16565077
• MDR Text Key: 311605177
• Report Number: 1018233-2023-01827
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• 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 Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/02/2023
• 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 Number: 1
• Patient Outcome(s): Other