MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	INX1130S19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information from a clinic stating that a patient has passed away.There is no allegation that the dreamstation bipap avaps device contributed to the death.It is unknown if the patient was on/using the device during the time of death.The clinical assessment team states that the reported event makes no allegation of any specific device malfunction, user error, failure, labeling, or other deficiency that is relevant to the harms reported.Based on available information at this time, the alleged death is assessed as not related to the device in this case.Therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.No further action is required.If additional information is obtained about this event, please send it to the pms clinical expert for review.The device has not been returned to the manufacturer.At this time, we are unable to confirm any malfunction of the device.A supplemental report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
This notification was re-evaluated following receipt and review of all available information related to the reported patient death.At the time of initial reporting, the event was conservatively submitted due to the limited information available.However, subsequent review confirms that there is no allegation or evidence suggesting that the device malfunctioned, failed, or otherwise contributed to the reported outcome.Specifically: no device deficiency (e.G., malfunction, misuse, labeling issue, or performance failure) has been identified.No causal or contributory relationship between the device and the reported death has been established.The available information indicates the death is attributable to factors unrelated to the device.Additionally, the clinical assessment team states 'the reported event makes no allegation of any specific device malfunction, user error, failure, labeling, or other deficiency that is relevant to the harms reported.Based on available information at this time, the alleged death is assessed as not related to the device in this case.Therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.No further action is required.' based on the totality of evidence, this event does not meet the criteria for reportability, as there is no reasonable possibility that the device caused or contributed to the death.Therefore, this case has been reassessed and determined to be non-reportable.The event will continue to be documented and trended per internal quality system requirements.If new information becomes available that changes the outcome of the associated medical device reporting, a supplemental report will be completed.

• Brand Name: DREAMSTATION BIPAP AVAPS
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22207829
• Report Number: 2518422-2025-106623
• Device Sequence Number: 7723169
• Product Code: MNS
• UDI-Device Identifier: 00606959425071
• UDI-Public: (01)00606959425071
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: INX1130S19
• Device Catalogue Number: INX1130S19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• 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