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

Model Number	GBG502S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A continuous positive airway pressure (cpap) device was returned to a third party service center for service.There was no report of patient harm or injury.During evaluation at a third party service center, the sound abatement foam was found to be degradation.The manufacturer's investigation in on-going.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported on this device in mdr 2518422-2022-09550.This report was submitted as a duplicate report of the previously submitted report.

• Brand Name: DREAMSTATION GO AUTO W/BT
• 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 15688 ; 7247330200
• MDR Report Key: 11885626
• Report Number: 2518422-2021-01446
• Device Sequence Number: 11670945
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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: GBG502S15
• Device Catalogue Number: GBG502S15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021; Not provided
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/26/2021; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• 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
• Patient Sex: Unknown