BEUDAMED
    FDA Adverse Event Summary report: N

    BABY LOG

    MDR report key: 1202858 · Received September 25, 2008

    Report

    Report Number
    1202858
    Date Received
    September 25, 2008
    Date of Event
    May 14, 2008
    Report Date
    September 19, 2008
    Manufacturer
    DRAEGER MEDICAL AG & CO. KGAA
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR FAILED WITH A CODE 803 ALARM. REVIEW OF THE VENT'S ALARM LOG HISTORY SHOWED ERROR CODE 823 THAT REFERS TO A CIRCUIT BOARD PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY LOG VENTILATOR, INFANT CBK DRAEGER MEDICAL AG & CO. KGAA BABY LOG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA