MAUDE Adverse Event Report: RESPIRONICS, INC. DORMA 100; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	INV101
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cancer (3262); Speech Disorder (4415)
Date of Event	01/04/2024
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.This report was related to a dorma 100 device.The manufacturer received voluntary medwatch (mw5155710) alleging dysphonia, otolaryngology follow-up and epidermoid carcinoma of the left vocal cord.Medical intervention was not specified.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
As per additional information received on 09/29/2025: despite good faith effort attempts, the device has not yet been returned to the manufacturer for evaluation.There has been no communication from the customer on the return of the device.At this time, philips is not able to fully investigate this complaint.If any additional information is received, a supplemental report will be filed.In this report, box h has been updated/corrected.

• Brand Name: DORMA 100
• 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: 23026307
• Report Number: 2518422-2025-049197
• Device Sequence Number: 9428288
• Product Code: BZD
• UDI-Device Identifier: 00606959006911
• UDI-Public: (01)00606959006911
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/01/2025

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: INV101
• Device Catalogue Number: INV101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2016
• 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: Other
• Patient Sex: Unknown