BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 4110193 · Received September 11, 2014

    Report

    Report Number
    8010042-2014-00389
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    PMA / PMN Number
    K023354
    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 WAS INVESTIGATED AT THE HOSPITAL BY OUR FIELD SERVICE ENGINEER. ONE OF THE FUSES WAS FOUND BLOWN IN THE MAINS INLET. THE MAINS INLET AND THE FUSES WERE REPLACED, AFTER A SUCCESSFUL FUNCTIONAL CHECK THE COMPRESSOR WAS RETURNED BACK TO SERVICE. FURTHER INVESTIGATION HAS NOT BEEN PERFORMED, BUT EARLIER INVESTIGATIONS DETERMINED THAT THE CAUSE OF THE 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, AFFECTING THE CONTACT BETWEEN THE FUSE AND FUSE HOLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR COULD NOT BE TURNED ON. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563116 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1