BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX W/HUMID

    MDR report key: 12301832 · Received August 10, 2021

    Report

    Report Number
    2518422-2021-02891
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 20, 2021
    Report Date
    October 29, 2025
    Manufacturer
    RESPIRONICS, INC
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058. CORRECTED DATA: D8 WAS THE DEVICE SERVICED BY A THIRD PARTY?: PREVIOUSLY REPORTED AS NO ; UPDATED TO UNKNOWN G4 PMA/510(K) NUMBER: PREVIOUSLY REPORTED AS K113068 ; UPDATED TO K131982.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT 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
    1200781 REMSTAR AUTO A-FLEX W/HUMID VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC IN551HS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown