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

Model Number	BRG502S18
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cancer (3262); Unspecified Respiratory Problem (4464)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient developed a spot on her lung.The patient did require medical intervention in the form of prescribed medication.The manufacturer's investigation is ongoing.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 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 previously received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient developed a spot on her lung.The patient did require medical intervention in the form of prescribed medication.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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 previously received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient developed a spot on her lung.The patient did require medical intervention in the form of prescribed medication.The device was returned to the manufacturer for investigation.Upon receipt, the device was found to have recorded 356.7 blower hours and 356.7 machine or operation hours.During the evaluation of the device at the service center the device log files were successfully downloaded and reviewed in full.No errors were noted in the log files.In addition, there was no evidence of foam degradation.The device was scrapped.In the initial report, the manufacturer submitted the allegation as both an adverse event and a product problem.Upon further review, it has been determined that the event involving the "spot on lung requiring prescribed medication" should have been reported as a product problem only.The review concluded that the event does not meet the criteria for a serious injury as defined in pepf 16.2.8.3 and under 21 cfr 803.3.The manufacturer has updated b1, adverse event or product problem to product problem only in this report.In the previous report, both were selected.The manufacturer has updated b2, outcomes attributed to adverse event to blank in this report.In the previous report, other serious or important medical events was selected for b2.The manufacturer has updated h1, type of reportable event, to malfunction in this report.In the previous report, serious injury was selected.The manufacturer has also corrected the health effect clinical code and health effect impact code in this report.In the initial report, the manufacturer coded the health effect clinical code as cancer.The manufacturer has updated the health effect clinical code to unspecified respiratory problem in this report.In the initial report the manufacturer coded health effect impact code to medication required.The manufacturer has also added the health effect impact code minor injury/ illness / impairment in this report.The manufacturer has updated h6 in this report.

• Brand Name: DREAMSTATION GO AUTO W/BT, BRAZIL
• 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: 12322683
• Report Number: 2518422-2021-03100
• Device Sequence Number: 4454361
• Product Code: BZD
• UDI-Device Identifier: 00606959056930
• UDI-Public: 00606959056930
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 10/15/2025

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: BRG502S18
• Device Catalogue Number: BRG502S18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 04/05/2023; 09/19/2023
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/13/2021; 08/29/2023; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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: Female