BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 39717 · Received September 26, 1996

    Report

    Report Number
    8010042-1996-00013
    Event Type
    Malfunction
    Date Received
    September 26, 1996
    Date of Event
    August 22, 1996
    Report Date
    September 26, 1996
    Manufacturer
    SIEMENS-ELEMA AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR SHUT DOWN WITHOUT ACTIVATING THE FAB BOX ALARM. THE USER WAS ALERTED BY THE HUMIDIFIER'S TEMP ALARM. THE UNIT WAS TESTED BY THE BIOMEDICAL DEPT. IT WAS ESTABLISHED THAT THE FUSES F1 AND F2 ON THE POWER SUPPLY BOARD WERE DEFECTIVE. AFTER INSTALLATION OF NEW FUSES, THE VENTILATOR WAS FOUND TO FUNCTION ACCORDING TO ITS SPECS. NO PT INJURY OCCURRED. NO PROBLEMS WITH THE MAINS OR THE EMERGENCY GENERATOR HAS BEEN ESTABLISHED BY THE CUSTOMER. ON 6/14/96, THE CUSTOMER REPLACED THE POWER SUPPLY BOARD DUE TO ANOTHER MALFUNCTION. INTERNAL # V96115.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO VENTILATOR 300 VENTILATOR CBK SIEMENS-ELEMA AB SV300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention