BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 13257498 · Received January 14, 2022

    Report

    Report Number
    2518422-2022-01013
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 16, 2021
    Report Date
    May 26, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005853
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 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. A CORRECTION TO B5 WAS MADE AND SHOULD BE: THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED. IN INITIAL REPORT, SECTION B7 WAS NOT CAPTURED, SECTION G3 DATE WAS WRONGLY CAPTURED AS 12/16/2022, SHOULD BE 12/16/2021, SECTION G4 510(K) NUMBER WAS WRONGLY CAPTURED AS K113068, SHOUD BE K131982 AND SECTION G1 CAPTURED AS "RESPIRONICS INC" INSTEAD OF "PHILIPS RESPIRONICS". CORRECTED AND UPDATED THESE FEILDS IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754536 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. AH560S 00606959005853

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown