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

Model Number	101V
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Headache (1880); Taste Disorder (4422); Cough (4457); Wheezing (4463); Eye Irritation (4803); Breath odor (4909)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information regarding a dorma 100 cpap device.The patient claims a fault occurred with the device which resulted in them inhaling particulate matter through their nasal mask.The patient alleges nausea, breathless and wheezing, headache, terrible smell and taste in nose and on saliva, chesty cough, itchy eyes, as well as feeling ill and tired.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information regarding a dorma 100 cpap device.The patient claims a fault occurred with the device which resulted in them inhaling particulate matter through their nasal mask.The patient alleges nausea, breathless and wheezing, headache, terrible smell and taste in nose and on saliva, chesty cough, itchy eyes, as well as feeling ill and tired.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The device was returned to the philips product investigation lab (pil) for further evaluation.The product investigation lab initiated therapy with the device and verified airflow, using a known good power supply and ac power cord.Evidence of sound abatement foam degradation/breakdown was not observed in this device.Dust-like contamination was observed at the air inlet, on the pca, in the blower box, and throughout the inside enclosure.White dust-like contamination was observed at the air inlet and the inside bottom of the blower box.The device was missing the air inlet filter.The philips product investigation lab can confirm the presence of multiple contaminants that are not consistent with degraded sound abatement foam from the secondary findings.The product investigation lab was unable to confirm the complaint or address the symptoms specified.The manufacturer is submitting a final report at this time.

• Brand Name: DORMA 100
• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 21260896
• Report Number: 2518422-2025-101405
• Device Sequence Number: 21205810
• Product Code: BZD
• UDI-Device Identifier: 00606959038424
• UDI-Public: (01)00606959038424
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: Lay User/Patient
• Device Model Number: 101V
• Device Catalogue Number: 101V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2017
• 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