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

Model Number	AHX700H11
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545); Eye Irritation (4803)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.
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 with eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness, headache.There was no serious patient harm or injury.No medical intervention was specified by the patient.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
Updated product brand name (rfb)/ product brand name, model number (rfb)/model number, catalog item identifier (rfb)/catalog item identifier, serial number (rfb)/serial number, product udi (rfb)/product udi, manufacture date (rfb)/manufacture date.
Additional Manufacturer Narrative
Mdr 2518422-2024-55357 is the original report associated with this device.A duplicate report has been submitted for this device under report mdr 2518422-2025-000806.This follow up report is being filed for awareness of this duplicate report.
Additional Manufacturer Narrative
Please note that this report is a duplicate and the event has already been reported under mdr 2518422-2024-55357.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 21105508
• Report Number: 2518422-2025-000806
• Device Sequence Number: 8758472
• Product Code: BZD
• UDI-Device Identifier: 00606959022638
• UDI-Public: (01)00606959022638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• 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,Followup,Followup
• Report Date (Section B): 10/17/2025

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: AHX700H11
• Device Catalogue Number: AHX700H11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 03/02/2025; 10/25/2025; 10/09/2023
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/02/2025; 09/25/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2016
• 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