MAUDE Adverse Event Report: Respironics, Inc. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	JPX500S16
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
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 an issue related to a cpap device's sound abatement foam.The patient has alleged visualization of black particles.There was no report of patient harm or injury.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 received new and relevant information on 07/29/2024.The device was returned to the service center for evaluation.During the evaluation of the device, the service center internally/ externally inspected the device confirmed that black dirt adhered to the air outlet port area and to the surface of the device.Confirmed by internal checking that an improved sound abatement foam was installed.Confirmed that the black particles or dirt were not confirmed in the inside of the sound abatement foam.Additionally, degradation of the sound abatement foam was not confirmed either.Therefore, it is assumed that the black dirt on the air outlet port area and the surface of the device adhered due to the living environment.Section g3 and h6 have been updated in this follow up report.

• Brand Name: DREAMSTATION AUTO CPAP
• 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 ; +1(724)733-0200
• MDR Report Key: 19812241
• Report Number: 2518422-2024-46656
• Device Sequence Number: 8302841
• Product Code: BZD
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131982
• 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,Followup
• Report Date (Section B): 09/04/2026

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: JPX500S16
• Device Catalogue Number: JPX500S16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 07/29/2024; Not provided
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/24/2025; 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2019
• 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
• Usage of Device: N
• 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