MAUDE Adverse Event Report: RESPIRONICS, INC. DS2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX520H15C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Sneezing (2251); Unspecified Respiratory Problem (4464)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer previously reported an event 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 visualization of greyish particles in the device waterbank.The patient has contacted mediq (the distributor) with this complaint but does not feel he is taken seriously.The patient reports visualization of gray flakes several times in the morning even when usage was short.The patient also reports being awaken by a persistent runny nose with subsequent sneezing.The patient's device has been exchanged a few times.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device is not related to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.Box b: adverse event or product problem; describe event or problem should state, "the manufacturer received information alleging visualization of greyish particles in the device waterbank.The patient has contacted mediq (the distributor) with this complaint but does not feel he is taken seriously.The patient reports visualization of gray flakes several times in the morning even when usage was short.The patient also reports being awaken by a persistent runny nose with subsequent sneezing.The patient's device has been exchanged a few times.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
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 visualization of greyish particles in the device waterbank.The patient has contacted mediq (the distributor) with this complaint but does not feel he is taken seriously.The patient reports visualization of gray flakes several times in the morning even when usage was short.The patient also reports being awaken by a persistent runny nose with subsequent sneezing.The patient's device has been exchanged a few times.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 device has not yet been returned to the manufacturer for investigation.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.H6 is updated/ corrected.

• Brand Name: DS2 ADV 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: 18980224
• Report Number: 2518422-2024-15085
• Device Sequence Number: 12336954
• Product Code: BZD
• UDI-Device Identifier: 00606959062818
• UDI-Public: 00606959062818
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2026

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: BLX520H15C
• Device Catalogue Number: BLX520H15C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 03/14/2024; 01/17/2025; 06/04/2026
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 03/27/2024; 01/17/2025; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown