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

Model Number	INX500S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/08/2024
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 patient alleges having lung discomfort.The patient states that the device was replaced by a new one on (b)(6) 2021.There is no allegation of serious or permanent harm or injury.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
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 patient alleges having lung discomfort.The patient states that the device was replaced by a new one on december 2, 2021.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The updated describe event or problem will be: a device was returned to manufacturer's service center for evaluation and was corrected.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, device serviced by 3rdp?, device available for eval?, device available for eval?, date returned to mfg are updated in this follow-up.In box g: date received by mfg is updated in this follow-up.In box h: device avail.For eval? (rfb), device evaluated by mfg?, evaluation method code grid, evaluation results code grid, component code grid, conclusion code grid are updated in this follow-up.

• 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 ; 7247330200
• MDR Report Key: 18763987
• Report Number: 2518422-2024-09313
• Device Sequence Number: 4387272
• Product Code: BZD
• UDI-Device Identifier: 00606959025875
• UDI-Public: (01)00606959025875
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: INX500S15
• Device Catalogue Number: INX500S15
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2018
• 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