MAUDE Adverse Event Report: RESPIRONICS, INC. DORMA 500 AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CNV507HN1
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Respiratory Failure (2484); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/22/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging patient started felt uncomfortable after using the ventilator device.Patient was hospitalized due to cold and snoring.Additionally, the patient was passed away due to severe osa, respiratory failure, laryngeal obstruction the device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer received new and relevant information on 09/09/2025.The device was returned to the service center for evaluation.During the evaluation of the device, the service center internally/ externally inspected the device pca was replaced.The device passed all tests.Section g3 and h6 have been updated in this follow up report.

• Brand Name: DORMA 500 AUTO
• 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: 18241627
• Report Number: 2518422-2023-32732
• Device Sequence Number: 12541779
• Product Code: BZD
• UDI-Device Identifier: 00606959040410
• UDI-Public: 00606959040410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CNV507HN1
• Device Catalogue Number: CNV507HN1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Sex: Unknown