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

Model Number	DE462S
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
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 device was returned to a third-party service center for evaluation.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of foam particles or degradation inside the assembly.Secondary findings include dust/dirt contamination inside the device.In addition, the devices error log was downloaded, and two error codes were present when reviewed.Lastly, the device was scrapped.
Additional Manufacturer Narrative
The manufacturer previously reported information 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 device was returned to a third-party service center for evaluation.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of foam particles or degradation inside the assembly.Secondary findings include dust/dirt contamination inside the device.In addition, the devices error log was downloaded, and two error codes were present when reviewed.Lastly, the device was scrapped.After further investigation, it has been determined that the dust contamination was mistaken for foam.Based on the information available at this time of investigation, it has been determined that there is no evidence that the device malfunctioned in a manner that would be likely to cause or contribute to death or serious injury if it were to recur.There was no serious patient harm or injury associated with this device and no increased risk to the intended user.Based on the information available, it is a non-reportable complaint.

• Brand Name: REMSTAR PRO 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 21053619
• Report Number: 2518422-2025-00001
• Device Sequence Number: 15492133
• Product Code: BZD
• UDI-Device Identifier: 00606959030220
• UDI-Public: (01)00606959030220
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DE462S
• Device Catalogue Number: DE462S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2014
• 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
• Patient Sex: Unknown