MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PLUS W/C-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1009871
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information from the patient's sister stating that the patient passed away.She wanted to know what she could do with the remstar plus w/ c-flex device.There was no allegation of malfunction or that the device caused or contributed to the death.The caller was directed to a dme or electronics bin to dispose of the device.Additional information has been requested regarding the details of the reported death.No medical intervention was reported.The manufacturer's investigation is ongoing.The device has not yet been returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
This report is submitted to provide additional information from the manufacturer's final investigation findings and to include the related coding fields and date received by mfg.The manufacturer previously reported: "the manufacturer received information from the patient's sister stating that the patient passed away.She wanted to know what she could do with the remstar plus w/ c-flex device.There was no allegation of malfunction or that the device caused or contributed to the death.The caller was directed to a durable medical equipment (dme) location or electronics bin to dispose of the device.Additional information has been requested regarding the details of the reported death.No medical intervention was reported.The manufacturer's investigation is ongoing.The device has not yet been returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete." the product associated with this complaint was not returned to the manufacturer.This report is being sent to conclude that no further investigation is possible.No device has been returned.No further evaluation is possible at this time.Multiple attempts to have the device returned for evaluation and investigation were unsuccessful.In addition, capa pr 7211 documents the investigation into similar complaints, correction/removal activities have been initiated (refer to h.9), and complaint code trending is reviewed on a periodic basis to evaluate field quality performance, and as an input to risk management activities.

• Brand Name: REMSTAR PLUS W/C-FLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 22212183
• Report Number: 2518422-2025-106655
• Device Sequence Number: 8158236
• Product Code: BZD
• UDI-Device Identifier: 00606959028647
• UDI-Public: (01)00606959028647
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 1009871
• Device Catalogue Number: 1009871
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2004
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown