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

Model Number 50000000

Device Problems Circuit Failure (1089); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that the arctic sun device had alarm 74 (non-recoverable system error).Mss discussed this indicates that the tank harness needed to be replaced.Biomed stated they would order and replaced the harness onsite.Per additional information on 11-jan-2023, based on the reported issue, all information needed had been received and there was no patient involvement reported.Per tech support communication with the biomed the t2 thermistor shorted, so biomed would replace the tank harness onsite.

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 had alarm 74 (non-recoverable system error).Mss discussed this indicates that the tank harness needed to be replaced.Biomed stated they would order and replaced the harness onsite.Per additional information on 11-jan-2023, based on the reported issue, all information needed had been received and there was no patient involvement reported.Per tech support communication with the biomed the t2 thermistor shorted, so biomed would replace the tank harness onsite.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a shorted t2 thermistor.Mss discussed this indicates that the tank harness needed to be replaced.Biomed stated they would order and replaced the harness onsite.Per additional information, based on the reported issue, all information needed had been received and there was no patient involvement reported.Per tech support communication with the biomed the t2 thermistor shorted, so biomed would replace the tank harness onsite.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.It is known that the device did not meet specifications and that the device was influenced by the reported failure.The device was not in use on a patient.The dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The labelling review is not required as the complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Correction: f,h.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.

• 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: 16241896
• MDR Text Key: 308276696
• Report Number: 1018233-2023-00310
• 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: 06/15/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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