BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVERY

    MDR report key: 1367928 · Received April 22, 2009

    Report

    Report Number
    MW5010852
    Event Type
    Injury
    Date Received
    April 22, 2009
    Date of Event
    March 4, 2009
    Report Date
    April 10, 2009
    Manufacturer
    AVERY BIOMEDICAL DEVICES
    Product Code
    GZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO DEVICE FAILURE, THE PATIENT WAS WEANED FROM THE VENTILATOR USING BILATERAL DIAPHRAGMATIC PACERS. THE RIGHT PACER FAILED. BY HISTORY FROM THE PATIENT'S MOTHER, THE PACER WAS HIT AGAINST THE PATIENT'S WHEELCHAIR AND SUBSEQUENTLY STOPPED WORKING. THE PATIENT WAS THEN PLACED BACK ON THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVERY I-110A RECEIVER; AVERY DIAPHRAGMATIC PACER GZE AVERY BIOMEDICAL DEVICES I-110A

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention