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	Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient with an dreamstation auto cpap device has passed away.There was no allegation that the device caused or contributed to the death.Additional information has been requested regarding the details of the reported death.The reporter did not provide the patient's date of death.The device has been requested for return.The device will not be returned for investigation, the device will be returned to stock.If any additional information becomes available this decision will be re-evaluated using the date of the repair evaluation as the "become aware" date if a reportable issue/malfunction is identified.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a patient with an dreamstation auto cpap device has passed away.There was no allegation that the device caused or contributed to the death.Additional information has been requested regarding the details of the reported death.The reporter did not provide the patient's date of death.The device has been requested for return.The device will not be returned for investigation, the device will be returned to stock.If any additional information becomes available this decision will be re-evaluated using the date of the repair evaluation as the "become aware" date if a reportable issue/malfunction is identified.Update: the manufacturer received information alleging a patient with an dreamstation auto cpap device has passed away.There was no allegation that the device caused or contributed to the death.Additional information has been requested regarding the details of the reported death.The reporter did not provide the patient's date of death.The device has been returned, but not yet evaluated.The manufacturer's investigation is ongoing.Section h: evaluation method code updated.Evaluation results code updated.Conclusion code updated.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a patient with an dreamstation auto cpap device has passed away.There was no allegation that the device caused or contributed to the death.Additional information has been requested regarding the details of the reported death.During evaluation of the device at a third party service center, no evidence of foam particles was found.No other device problems were found.The device passed all tests.Section d, g3 and box h has been updated/corrected.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19541180
• Report Number: 2518422-2024-36836
• Device Sequence Number: 7550490
• Product Code: BZD
• UDI-Device Identifier: 00606959042285
• UDI-Public: (01)00606959042285
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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: Other
• Device Model Number: GBX500S15
• Device Catalogue Number: GBX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: Not provided; 09/05/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/28/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• 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