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

Model Number	GBX500S15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Death
Event or Problem Description
The manufacturer became aware of an allegation that an end user has passed away while using a dreamstation auto cpap.There is no allegation that the device contributed to the death.No other clinical information or medical interventions were reported.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
H3 other text : the device has not yet been returned to the manufacturer.
Additional Manufacturer Narrative
The manufacturer was previously became aware of an allegation that an end user has passed away while using a dreamstation auto cpap.There is no allegation that the device contributed to the death.No other clinical information or medical interventions were reported.The updated describe event or problem will be: the device was returned to an authorized service center for evaluation.The device was visually inspected.During the evaluation, the service center founds no faults and the device passed all tests.In box d: product udi, device serviced by 3rdp?, device available for eval?, device available for eval?, date returned to mfg are updated in this follow-up.In box g: date received by mfg is updated in this follow-up.In box h: device avail.For eval? (rfb), device evaluated by mfg?, evaluation method code grid, evaluation results code grid, component code grid, conclusion code grid are updated in this follow-up.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 18620766
• Report Number: 2518422-2024-05186
• Device Sequence Number: 12611987
• Product Code: BZD
• UDI-Device Identifier: 00606959023222
• UDI-Public: (01)00606959023222
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: GBX500S15
• Device Catalogue Number: GBX500S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 11/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown