BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO

    MDR report key: 770075 · Received October 11, 2006

    Report

    Report Number
    MW1040684
    Event Type
    Injury
    Date Received
    October 11, 2006
    Date of Event
    September 27, 2006
    Report Date
    October 6, 2006
    Manufacturer
    SIEMANS/MAQUET INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IS A MALE WHO ARRIVED AT MEDICAL CENTER IN THE EVENING WITH AN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. HE UNDERWENT CARDIAC CATHETERIZATION WITH PERCUTANEOUS CORONARY INTERVENTION, INTRA-AORTIC BALLOON PUMP PLACEMENT, AND WAS INTUBATED FOR AIRWAY PROTECTION. HE WAS TRANSFERRED TO THE CCU AND PLACED ON MAQUET SERVO 300 VENTILATOR. AT APPROXIMATELY 3:00AM, THE VENTILATOR STOPPED DELIVERING BREATHS, TRIGGERING THE ALARM SYSTEM. MANUAL VENTILATION WAS MAINTAINED UNTIL REPLACEMENT VENTILATOR ARRIVED. NO PATIENT COMPROMISE. VENTILATOR WAS SEQUESTERED AND MANUFACTURER INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO VENTILATOR CBK SIEMANS/MAQUET INC 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention