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

Model Number	GBG502S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient observed black particles blowing out of the device.The patient was diagnosed with cancer.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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 visualization of black particles blowing out of the device related to a cpap device's sound abatement foam.The patient was diagnosed with cancer.No medical intervention was specified.Since there is no customer information, the manufacturer believes they will be unable to gather information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.
Additional Manufacturer Narrative
Additional information was received on 02/18/2025.The device was returned to the manufacturer's service center for further evaluation.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The device powered on, and the airflow was confirmed.The device's downloaded logs were reviewed.The manufacturer concludes that the customer allegation could not be confirmed and there was no visible foam degradation.The unit has been scrapped.Sections d8, d9, h3 and h6 updated.

• Brand Name: DREAMSTATION GO 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243512041
• MDR Report Key: 13581387
• Report Number: 2518422-2022-06935
• Device Sequence Number: 5644457
• Product Code: BZD
• UDI-Device Identifier: 00606959048676
• UDI-Public: 00606959048676
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: GBG502S15
• Device Catalogue Number: GBG502S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 11/08/2023; 02/18/2025
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 11/08/2023; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2018
• 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
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown