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

Model Number	507V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2024
Type of Reportable Event	Death
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 an issue related to a dorma 500 device's sound abatement foam.There was report of patient death.The manufacturer's investigation is ongoing.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported on this device in mdr 2518422-2023-32732.This report was submitted as a duplicate report of the previously submitted report.

• Brand Name: DORMA 500 AUTO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIR ATOR)
• 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: 23756741
• Report Number: 2518422-2025-058880
• Device Sequence Number: 21173508
• Product Code: BZD
• UDI-Device Identifier: 00606959038530
• UDI-Public: (01)00606959038530
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 507V
• Device Catalogue Number: 507V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2020
• 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
• Patient Sex: Unknown