BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 3110540 · Received April 8, 2013

    Report

    Report Number
    3008355164-2013-00081
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR WAS MAKING NOISE AND SMOKING WHEN TURNED UP PRIOR TO PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144329 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA