BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 3770421 · Received February 18, 2014

    Report

    Report Number
    8010042-2014-00029
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    PMA / PMN Number
    K023354
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPRESSOR MINI WAS EXAMINED AT THE HOSPITAL BY OUR COMPANY REP. ONE OF THE FUSES WAS FOUND BLOWN. THE MAIN INLET AND FUSES WERE REPLACED AND AFTER A SUCCESSFUL FUNCTION CHECK THE COMPRESSOR WAS RETURNED TO SERVICE. FURTHER INVESTIGATION HAS NOT BEEN PERFORMED BUT EARLIER INVESTIGATIONS DETERMINED THAT THE CAUSE OF A BLOWN FUSE COULD BE ONE OF 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COMPRESSOR MINI CONNECTED TO A VENTILATOR HAD NO PRESSURE. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102300 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA