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

Model Number	INV501H
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Cough (4457); Unspecified Respiratory Problem (4464); Eye Irritation (4803)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
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 intense cough and breathing obstruction.In addition, the patient reported problems with breathing, and constant use of drops for the nose and eyes (in the last two years) due to constant irritation of the mucous membranes of the nose and eyes.The manufacturer's investigation is ongoing.If any additional information is received, a follow up report will be filed.

• 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: 23526403
• Report Number: 2518422-2025-051600
• Device Sequence Number: 21103208
• Product Code: BZD
• UDI-Device Identifier: 00606959036956
• UDI-Public: (01)00606959036956
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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
• Report Date (Section B): 11/11/2025

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: INV501H
• Device Catalogue Number: INV501H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2018
• 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: Hospitalization
• Patient Sex: Unknown