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

Model Number	AU461S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
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 manufacturer received information alleging visualization of black particles in the mask.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
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 previously received information alleging an issue related to the cpap device's sound abatement foam.The patient alleged visualization of black particles in the mask.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.No device has been returned.No further evaluation is possible at this time.A final report is being submitted.If new information becomes available that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• Brand Name: REMSTAR PRO C-FLEX+
• 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 15736414
• Report Number: 2518422-2022-91633
• Device Sequence Number: 6225752
• Product Code: BZD
• UDI-Device Identifier: 00606959005440
• UDI-Public: 00606959005440
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: AU461S
• Device Catalogue Number: AU461S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2013
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Male