BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 3014230 · Received March 12, 2013

    Report

    Report Number
    8010042-2013-00033
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 2013
    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

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. THE MAINS INLET AND THE FUSES WERE REPLACED. THE REPLACED PARTS HAVE BEEN REQUESTED FOR INVESTIGATION BUT NOT YET RECEIVED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR COULD NOT POWER UP. THERE WAS NO IMPACT ON PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104235 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA