BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 3110550 · Received April 8, 2013

    Report

    Report Number
    8010042-2013-00045
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    PMA / PMN Number
    K023354
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPRESSOR MINI WAS EXAMINED AT THE HOSPITAL BY OUR COMPANY REPRESENTATIVE. ONE OF THE FUSES WAS FOUND BLOWN AND STUCK IN THE MAIN INLET. ONE END OF THE FUSE WAS CHARRED. VISUAL INSPECTION SHOWED THAT THE MAIN INLET WAS FULL OF LINT AND DUST. THE MAIN INLET AND FUSES WERE REPLACED AND AFTER A SUCCESSFUL FUNCTION CHECK THE COMPRESSOR WAS RETURNED TO SERVICE. THE CAUSE OF A BLOWN FUSE COULD BE ONE OR A COMBINATION OF THE FOLLOWING CAUSES: ELECTRICAL TRANSIENTS (VOLTAGE AND/OR CURRENT SPIKES) IN THE MAINS POWER. BAD ELECTRICAL CONNECTION BETWEEN THE FUSE AND THE FUSE HOLDER, E.G. DUE TO VIBRATIONS IN THE SYSTEM. CHEMICALS USED FROM CLEANING THE DEVICE (BY SPRAYING) CAUSING CORROSION AND AS SECOND EFFECT BAD CONNECTION. DUST IN THE ENVIRONMENT IF DEPOSITED ON THE FUSE HOLDER, WHICH WILL INSULATE AND INCREASE THE TEMPERATURE AROUND THE FUSE AND AFFECT THE CONTACT BETWEEN FUSE AND FUSE HOLDER. ACCORDING TO THE USER'S MANUAL, A PREVENTIVE MAINTENANCE SHALL BE PERFORMED AFTER 5000 OPERATING HOURS. IT INCLUDES VISUAL INSPECTION FOR DAMAGED PARTS AND PREVENTIVE CLEANING OF DUST IN THE MAIN INLET. THERE IS NO INFORMATION ABOUT WHEN THE LAST MAINTENANCE WAS DONE ON THIS DEVICE. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144334 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1