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

Model Number	FRX500S14
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Cough (4457); Unspecified Respiratory Problem (4464)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
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 "headaches, coughing, respiratory discomfort, congested bronchi itching, great fatigue impact on blood pressure stop respiratory assistance." no medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
In box b: describe event or problem will be: a device was returned to a third-party service center 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 "headaches, coughing, respiratory discomfort, congested bronchi itching, great fatigue impact on blood pressure stop respiratory assistance.During the evaluation of the device at the third-party service center, the device was visually inspected and no visible foam particles were observed.The device was repaired.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In box d: product udi (rfb), product udi, operator of device - other are updated in this follow-up.In box g: report source (rfb), report source, report source - other, date received by mfg are updated in this follow-up.In box h: (device) problem code grid, evaluation method code grid, evaluation results code grid, component code grid, conclusion code grid, remedial action init (rfb), remedial action initiated, recall (z) number (rfb), recall (z) number are updated in this follow-up.

• Brand Name: DREAMSTATION 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17745486
• Report Number: 2518422-2023-22927
• Device Sequence Number: 4145742
• Product Code: BZD
• UDI-Device Identifier: 00606959023574
• UDI-Public: (01)00606959023574
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: Other
• Device Model Number: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2016
• 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
• Patient Sex: Unknown