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

Model Number	FRX500S14
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Headache (1880)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
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 the user experiencing "headaches." there is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The device has not yet been returned to the manufacturer for evaluation, and there is no contact information for the initial reporter to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
H3 other text : the device has not been returned to the manufacturer.
Additional Manufacturer Narrative
As per additional information received on 08/28/2022: the device was returned to a third-party service center.During the evaluation of the device at the third-party service center, the device was visually inspected and visible foam particles were not observed.Additionally, the device was corrected.In this report, box d, h has been updated/corrected.

• 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: 17704158
• Report Number: 2518422-2023-22004
• Device Sequence Number: 20697303
• Product Code: BZD
• UDI-Device Identifier: 00606959043060
• UDI-Public: (01)00606959043060
• 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: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/28/2022
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2016
• 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 Age: 60 YR
• Patient Sex: Male