BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS INC/PHILIPS

    MDR report key: 4745511 · Received April 28, 2015

    Report

    Report Number
    MW5042450
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    April 4, 2015
    Report Date
    April 13, 2015
    Manufacturer
    RESPIRONICS
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER PLACING BIPAP VENT SUPPORT SYSTEM ON TO PT MACHINE STARTED TO ALARM AND SHUT OFF. PT BECAME ANXIOUS WITH INCREASED WORK OF BREATHING. SATS DECREASED TO 75% RESPIRATORY RATE INCREASED TO 30 AND HEART RATE TO 140. BIPAP MACHINE WAS NOT DELIVERING DESIRED INSPIRATORY PRESSURES. SETTINGS WERE: IPAP: 24, RATE: 10, FIO2: 25%, EPAP: 6, TIMED INSPIRATIONS: 0.9. MACHINE INSPECTED AND FOUND NOT DELIVERING DESIRED INSPIRATORY PRESSURES. LAST MAINTENANCE BY PHILIPS 11/04/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277383 RESPIRONICS INC/PHILIPS BIPAP VISION VENT SUPPORT SYSTEM MNT RESPIRONICS 582059

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention PLACED ON ANOTHER BIPAP VENT SUPPORT SYSTEM