BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1912457 · Received November 23, 2010

    Report

    Report Number
    8010042-2010-00267
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A PREVENTIVE MAINTENANCE, THE CUSTOMER REMOVED THE BATTERY MODULE AND REINSERTED IT WHILE THE VENTILATOR WAS TURNED ON. THE VENTILATOR SHUT DOWN AND WHEN IT CAME BACK ON, THE VENTILATOR WOULD ONLY ALARM RESTART VENTILATOR. THE CUSTOMER NOTICED THAT ALL INSTALLED OPTIONS AND EQUIPMENT HARDWARE AND SOFTWARE INFO WAS SHOWING "UNAVAILABLE". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1