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

Model Number	FRX500S14
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Chest Pain (1776); Cough (4457); Skin Inflammation/ Irritation (4545); Eye Irritation (4803)
Date of Event	03/22/2022
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 an issue related to a dreamstation auto device's sound abatement foam.The patient has alleged coughing, chest pain, skin and eye irritation.There was no report of harm or injury.No medical intervention was required by the patient.The device was returned to a third-party service center.The technician could not confirm foam particles in the device evaluation.The device was scrapped.The manufacturer is submitting a final report at this time.If any additional information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: DREAMSTATION AUTO
• 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: 20658241
• Report Number: 2518422-2024-69716
• Device Sequence Number: 7239019
• Product Code: BZD
• UDI-Device Identifier: 00606959023574
• UDI-Public: (01)00606959023574
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2018
• 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