BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 8841425 · Received July 30, 2019

    Report

    Report Number
    8010042-2019-00551
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Report Date
    February 19, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIELD SERVICE ENGINEER WAS ON SITE AND INVESTIGATED THE REPORTED ISSUE. THE BLOWN FUSES WERE REPLACED AND THE COMPRESSOR RETURNED TO CLINICAL USE. NO PARTS WERE RECEIEVED FOR FURTHER INVESTIGATION BUT 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. THE EXACT ROOT CAUSE IN THIS CASE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 232516

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR STOPPED WORKING. THERE WAS NO PATIENT HARM. MANUFACTURER REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635938 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB COMPR MINI 115V 60HZ

    Patients

    Seq Age Sex Outcome Treatment
    1