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	Sore Throat (2396)
Date of Event	04/24/2023
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 to seeing a white film floating in the water and is experiencing a sore throat and difficulty swallowing.There was no report of serious patient harm or injury.There was no medical intervention 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
The manufacturer was previously 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 to seeing a white film floating in the water and is experiencing a sore throat and difficulty swallowing.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The device was returned to the service center for evaluation.During servicing of the device, multiple two-millimeter foreign substances and fiber-like foreign substances were observed.There were no device failures identified and there is no report of degradation of the device's sound abatement foam.Section h6 and h9 have been updated accordingly.Udi related data quality updates only.The udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16843997
• Report Number: 2518422-2023-10096
• Device Sequence Number: 7547010
• Product Code: BZD
• UDI-Device Identifier: 00606959028265
• UDI-Public: (01)00606959028265
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: JPX500S16
• Device Catalogue Number: JPX500S16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2020
• 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: 58 YR
• Patient Sex: Male