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

Model Number	BLX500S15
Medical Device Problem Codes	Degraded (1153); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Anxiety (2328); Cough (4457)
Date of Event	09/16/2024
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 coughing and anxiety due to the use of the device.The patient reports coughing less since they received a revised device.The patient reports being anxious to use the old device due to the recall.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 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 coughing and anxiety due to the use of the device.The patient reports coughing less since they received a revised device.The patient reports being anxious to use the old device due to the recall.No medical intervention was required by the patient.At this time, no further investigation can be performed.The device has not yet been returned to the manufacturer for evaluation.The patient cannot be contacted for further information.If any additional information is received, a follow up report will be filed.
Event or Problem Description
This report is being submitted to correct the description of the event or problem previously reported.The dreamstation auto cpap was returned to a third-party service center for service prior to the complaint on 06/29/2022.The device was corrected, and sound abatement foam replacement occurred.The device does not fall under the recall notification related to the sound abatement foam.Furthermore, there is no evidence to suggest that the device malfunctioned in a way that could lead to death or serious injury if the issue were to recur.Therefore, this complaint is not reportable to any regulatory agencies.
Additional Manufacturer Narrative
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 coughing and anxiety due to the use of the device.The patient reports coughing less since they received a revised device.The patient reports being anxious to use the old device due to the recall.No medical intervention was required by the patient.At this time, no further investigation can be performed.The device has not yet been returned to the manufacturer for evaluation.The patient cannot be contacted for further information.If any additional information is received, a follow up report will be filed.This report is being submitted to correct the description of the event or problem previously reported.The dreamstation auto cpap was returned to a third-party service center for service prior to the complaint on 06/29/2022.The device was corrected, and sound abatement foam replacement occurred.The device does not fall under the recall notification related to the sound abatement foam.Furthermore, there is no evidence to suggest that the device malfunctioned in a way that could lead to death or serious injury if the issue were to recur.Therefore, this complaint is not reportable to any regulatory agencies.
Additional Manufacturer Narrative
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 coughing and anxiety due to the use of the device.The patient reports coughing less since they received a revised device.The patient reports being anxious to use the old device due to the recall.No medical intervention was required by the patient.It was previously incorrectly reported that the device was not related to the recall.After further review the device was determined to be related to the recall and therefore reportable.The device was returned to the manufacturer in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device, the device was visually inspected and found no evidence of foam degradation.The customer complaint was not addressed.The device was corrected.

• Brand Name: DREAMSTATION
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20389601
• Report Number: 2518422-2024-101675
• Device Sequence Number: 12411340
• Product Code: BZD
• UDI-Device Identifier: 00606959027343
• UDI-Public: (01)00606959027343
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup,Followup
• Report Date (Section B): 06/26/2025

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: Other
• Device Model Number: BLX500S15
• Device Catalogue Number: BLX500S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 06/11/2025; 06/12/2025; 06/16/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 06/11/2025; 06/13/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2017
• 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