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 Codes	Pain (1994); Unspecified Respiratory Problem (4464)
Date of Event	11/01/2011
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 the patient visualized black particles in the air outlet port of the device before and after the repair of replacing rp kits in november 2011.The patient reports nasal pain and nasal discharge after usage of the device.Medical intervention was not specified.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 the patient visualized black particles in the air outlet port of the device before and after the repair of replacing rp kits in november 2011.The patient reports nasal pain and nasal discharge after usage of the device.Medical intervention was not specified.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: 18012667
• Report Number: 2518422-2023-27866
• Device Sequence Number: 20679857
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2025

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: 10/11/2023
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2017
• 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