BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 17390213 · Received July 25, 2023

    Report

    Report Number
    2518422-2023-16766
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 8, 2021
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    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 MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE HAS AS A SERVICE REQUIRED MESSAGE AND "BEEPS THEN SHUTS DOWN AFTER A FEW MINUTES OF CUTTING OFF SYSTEM UPDATE REQ." THE PATIENT ALLEGES DIFFICULTY BREATHING/SHORT OF BREATH, MINOR HEADACHES, AND "RAPID BREATHING BEING CAUSED DURING USAGE WHILE SLEEP." IN ADDITION, THE PATIENT HAS SET AN APPOINTMENT TO MEET WITH THEIR HEALTH CARE PROVIDER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. ON THE PREVIOUSLY SUBMITTED REPORT, SECTION B1 WAS SELECTED AS A PRODUCT PROBLEM. AFTER FURTHER REVIEW, THIS REPORT IS NOW BEING FILED AS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM.

    Description of Event or Problem · 0

    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 THE DEVICE HAS AS A SERVICE REQUIRED MESSAGE AND "BEEPS THEN SHUTS DOWN AFTER A FEW MINUTES OF CUTTING OFF SYSTEM UPDATE REQ." THE PATIENT ALLEGES DIFFICULTY BREATHING/SHORT OF BREATH, MINOR HEADACHES, AND "RAPID BREATHING BEING CAUSED DURING USAGE WHILE SLEEP." IN ADDITION, THE PATIENT HAS SET AN APPOINTMENT TO MEET WITH THEIR HEALTH CARE PROVIDER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338986 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS450HS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other