BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3131568 · Received May 16, 2013

    Report

    Report Number
    3131568
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 16, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) MASK DISCONNECTED ON THREE DIFFERENT OCCASIONS CAUSING THE PATIENT TO DESATURATE. THE MASK DID NOT APPEAR TO SECURE TIGHTLY. PATIENT SETTINGS WERE 14/8, 100% FIO2, NON-HEATED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218486 * VENTILATOR BSZ PHILIPS MEDICAL SYSTEMS AF531 *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR