BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 3862224 · Received April 24, 2014

    Report

    Report Number
    8010042-2014-00185
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    October 9, 2013
    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 EXAMINED AT THE HOSPITAL BY OUR SERVICE TECHNICIAN. THE INSPECTION OF THE MAINS INLET REVEALED THAT BOTH FUSES WERE BLOWN. THE FUSES WERE REPLACED AND THE COMPRESSOR COULD REGAIN A NORMAL FUNCTION. AFTER A SUCCESSFUL FUNCTION CHECK, THE COMPRESSOR WAS RETURNED BACK TO SERVICE. FURTHER INVESTIGATION HAS NOT BEEN PERFORMED BUT EARLIER INVESTIGATIONS DETERMINED THAT 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 A 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. THIS EVENT WAS IDENTIFIED IN A RETROSPECTIVE REVIEW OF SERVICE ORDERS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR STOPPED WORKING. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249826 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1