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

Model Number 60000000

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

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

It was reported that this arctic sun device boots to an alarm 72 (non-recoverable system error).Biomed discussed this was an indicative of a shorted outlet monitor temperature (t1) thermistor.Per follow up information received via email on 06dec2022, the device was coming in for repair.The issue was found during a regular inspection and was no used for patient care.The biomed would send the device in for repair as soon as the loaner was received.

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 this arctic sun device boots to an alarm 72 (non-recoverable system error).Biomed discussed this was an indicative of a shorted outlet monitor temperature (t1) thermistor.As per follow up information received via email on 06dec2022, the device was coming in for repair.The issue was found during a regular inspection and was no used for patient care.The biomed would send the device in for repair as soon as the loaner was received.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is due to a tank harness failure.During evaluation, it was confirmed that the alarm 72 was present as it was seen in the event log.Initial test, device shows t1 at 99 (shorted thermistor).Tank harness was replaced.The device did not meet specifications and was influenced by the reported failure.The device was not in use on a device patient.The dhr is not required as this is not an out-of-box failure.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Correction- d, f, g, 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 actual/suspected device was inspected.

• Brand Name: ARCTIC SUN STAT
• 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: 15932632
• MDR Text Key: 305066992
• Report Number: 1018233-2022-09368
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60000000
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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