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

Model Number	FRX521H14C
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer previously received information alleging needs to be checked related to the device ds2adv auto cpap.There was no report of patient harm or injury.No medical intervention was specified.The device was returned to the third-party service center for evaluation.During the evaluation of the device at the third-party service center, there was evidence of burnt pca.Additionally, the blower and screws were corroded, and a new pollen filter was also required as part of preventive maintenance.The manufacturer previously reported the following information listed in quotes in error "the third-party service center was unable to complete the investigation, and the device will be forwarded to the manufacturer product investigation laboratory (pil) and investigated further".Please note that following further review of complaint information and device evaluation performed by third-party service center it was determined that the customer complaint which was the unit required inspection (¿customer needs check¿), was confirmed during evaluation.All functional tests were performed, and the unit passed final testing.In this report, box h has been updated/corrected.
Event or Problem Description
The manufacturer received information alleging needs to be checked related to the device ds2adv auto cpap.There was no report of patient harm or injury.No medical intervention was specified.The device was returned to the third-party service center for evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and found thermal event as the main pca was burnt.Additionally, blower and screws were corroded, and new pollen filter must be added.The customer complaint was reproduced.The third-party service center was unable to complete the investigation, and the device will be forwarded to the manufacturer product investigation laboratory (pil) and investigated further.

• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 23452119
• Report Number: 2518422-2025-051334
• Device Sequence Number: 20804495
• Product Code: BZD
• UDI-Device Identifier: 00606959062757
• UDI-Public: (01)00606959062757
• Combination Product (Y/N): N
• Initial Reporter Country: RE
• PMA/510(K) Number: K200480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 08/06/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2022
• 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