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

Model Number 60000000

Device Problem Disconnection (1171)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

It was reported that the arctic sun device was only taking 1.5 liters of water before saying it was full, emptied and retried using the instructions in the service manual and issue still present.The device was coming back as an out of box failure.Per review of wo on 11oct2022, there was no patient involved.Per follow up information received via email on 18oct2022, customer would be sending device in as an out of box failure per sample evaluation results received on (b)(6) 2022, during the evaluation the technician was looking into the short filling of water, when testing the wire came out of the plug of the chiller unit on the pc board now chiller needs replaced as well as the level gauge.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that the arctic sun device was only taking 1.5 litres of water before saying it was full, emptied and retried using the instructions in the service manual and issue still present.The device was coming back as an out of box failure.Per review of wo on 11oct2022, there was no patient involved.Per follow-up information received via email on 18oct2022, customer would be sending the device in as an out of box failure.Per sample evaluation results received on 25oct2022, during the evaluation the technician was looking into the short filling of water, when testing the wire came out of the plug of the chiller unit on the pc board now chiller needs to be replaced as well as the level gauge.

• 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: 15753581
• MDR Text Key: 307671417
• Report Number: 1018233-2022-08585
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• 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
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2022
• 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