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

Device Problem Partial Blockage (1065)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that low flow when in use of the arctic sun device and blockage alert.Upon checking, there was a sound of air leakage from the connector on the pad side.

Event Description

It was reported that low flow when in use of the arctic sun device and blockage alert.Upon checking, there was a sound of air leakage from the connector on the pad side.Per follow up information received via email on 19feb2024, unknown whether device be sent in for a bd-approved facility for evaluation.Unknown whether patient completed therapy on the original device.

Manufacturer Narrative

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

• Brand Name: UNKNOWN ARCTICSUN 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: 18425401
• MDR Text Key: 332615789
• Report Number: 1018233-2023-09394
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/17/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/18/2024
• 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