MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	FRX521H14C
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that the ds2adv auto cpap device does not light up.There was no report of serious patient harm or injury.There was no report that patient required medical intervention.The device was returned to a third-party service center for evaluation and the reported customer complaint was reproduced.During evaluation of the device, the third-party service center visually inspected the device and found no light from display, ui bezel defective, main board burn, blower outlet seal deformed, blower contaminated inside, in/out seal missing and new pollen filter must added.Lastly, the device was scrapped as per customer request.

• Brand Name: DS2ADV AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 21617582
• Report Number: 2518422-2025-035051
• Device Sequence Number: 6837703
• Product Code: BZD
• UDI-Device Identifier: 00606959062757
• UDI-Public: (01)00606959062757
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: FRX521H14C
• Device Catalogue Number: FRX521H14C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown