MAUDE Adverse Event Report: Respironics, Inc. DS2Adv Auto CPAP; Ventilator, Non-Continuous (Respirator)

Model Number	FRX521H14C
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the ds2adv auto cpap device.There was a report of error message "needs repair".There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device was returned to the third-party service center for evaluation.During the evaluation of the device there was evidence of component on pca is burned, the blower is corroded, the bower outlet seal/isolator, inlet/ outlet seal, iso port are contaminated iso port are contaminated with limestone, the screws are rusted.Pollen filter needs to be added for preventive maintenance.The device was requested to be sent to the manufacturer's product investigation lab (pil) for further investigation.

• Brand Name: DS2Adv Auto CPAP
• Common Device Name: Ventilator, Non-Continuous (Respirator)
• Manufacturer (Section D): Respironics, Inc.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): Respironics, Inc.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; +1(724)733-0200
• MDR Report Key: 50143102
• Report Number: 2518422-2026-041307
• Device Sequence Number: 9212298
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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: Other
• Device Model Number: FRX521H14C
• Device Catalogue Number: FRX521H14C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2021
• 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