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

Model Number	BLX500S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	07/17/2023
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 chronic respiratory system problems as well as injury to other organ systems which leads to material and immaterial damages.Medical intervention was not specified.No additional information can be requested at this time.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.
Additional Manufacturer Narrative
The device won¿t be returning to the manufacturer for further evaluation.The manufacturer is submitting a final report.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Event or Problem Description
Legal benelux team has received on (b)(6) 2024 further information from the attorney regarding the patient's complaint.The lawyer has clarified the serial number of their client's dreamstation device.And has also informed that the patient would like to keep the device and is contemplating starting legal expert proceedings.The device won¿t be returning to the manufacturer for further evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• 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: 19985191
• Report Number: 2518422-2024-51491
• Device Sequence Number: 7257984
• Product Code: BZD
• UDI-Device Identifier: 00606959027343
• UDI-Public: (01)00606959027343
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K091319
• Number of Events Summarized: 1
• Summary Report (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): 01/17/2025

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: BLX500S15
• Device Catalogue Number: BLX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2016
• 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