MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PRO C-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) - BZD

Model Number	460P
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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 received information that the patient alleging cancer prostate.There was no report of medical intervention.The manufacturer was made aware of this complaint through a representative of the customer.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacture inspected externally observed the sd card cover and water tank were missing.A greyish dust-like contamination was observed in the lcd area of the ui panel.A small scratch was observed on the front of the bottom enclosure.Dust-like contamination was observed on the right-side panel, in the air inlet, on the ui panel, all over the pca, on the interior side of the left panel, on the blower cap, on and in the blower motor, around the walls of the bottom enclosure and on the sound abatement foam.The manufacturer used a fitt (foam integrity test tool) and was not able to confirm the presence of degraded sound abatement foam.Manufacturer observed dust-like contamination on the humidifier flip lid assembly, inside the outlet port, on the left side panel, inside the humidifier bottom enclosure, on the flip lid assembly seal, on the dry box and dry box seals, in the lower base, and on the heater plate.Manufacturer observed a brownish contamination on the flip lid seal.Manufacturer observed a whitish dust-like contamination consistent with mineral deposits in the dry box outlet seal.The manufacturer concludes there was no evidence of sound abatement foam degradation and there is no visible damage or functionality failures of the device.The manufacturer observed dust contamination and water marks in the device and are consistent with being from an external source.

• Brand Name: REMSTAR PRO C-FLEX+
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR) - BZD
• 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: 22130587
• Report Number: 2518422-2025-046492
• Device Sequence Number: 7445597
• Product Code: BZD
• UDI-Device Identifier: 00606959030107
• UDI-Public: (01)00606959030107
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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: 460P
• Device Catalogue Number: 460P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown