BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTOA-FLEX

    MDR report key: 14450439 · Received May 20, 2022

    Report

    Report Number
    2518422-2022-21945
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    February 15, 2022
    Report Date
    September 20, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005891
    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 PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECOME DEGRADED AND CAUSE VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. IN PREVIOUS REPORT SECTION G3 SHOULD BE 02/15/2022 AND SECTION G4 SHOULD BE K131982, WHICH HAS BEEN CORRECTED / UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF PARTICLES. 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
    965511 REMSTAR AUTOA-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560HS 00606959005891

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown