BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AF531 EE LEAK 1 4 PT HDG, SU, SINGLE

    MDR report key: 8639693 · Received May 24, 2019

    Report

    Report Number
    8639693
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    January 14, 2019
    Report Date
    February 19, 2019
    Manufacturer
    RESPIRONICS INC.
    Product Code
    MNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTED THE EXHALATION VALVE BROKEN ON THE PATIENT'S MASK AND SATS DECREASED TO 77-80%. WATER HAD ACCUMULATED IN THE MASK, DUE TO THE HEATED MODE OF THERAPY AND THE PATIENT RUNNING A FAN ON THE MASK. THE WATER SETTLED IN THE EXHALATION VALVE AND DID NOT READ THE PRESSURE CORRECTLY ON THE MACHINE. OXYGEN SATS WERE 96% WHEN I ARRIVED TO THE ROOM. PT STATED HER BREATHING WAS BETTER (PRIOR TO THE MASK BEING CHANGED). THE PT HAD THE SAME MASK ON FOR THE PAST COUPLE OF DAYS. RESPIRATORY THERAPIST TEAM LEAD CHANGED THE MASK WHEN SHE NOTICED THE EXCESSIVE WATER. EXHALATION VALVE WAS NOT BROKE; INSTEAD, WATER NEEDED TO BE EMPTIED FROM THE MASK. NO ADVERSE REACTIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433893 AF531 EE LEAK 1 4 PT HDG, SU, SINGLE VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS INC. 180626

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA