BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 3980183 · Received July 2, 2014

    Report

    Report Number
    8010042-2014-00287
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 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 EXCHANGED PARTS HAVE BEEN SOUGHT FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. REFER TO EXEMPTION # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MAINTENANCE OF A COMPRESSOR, A WORN MOTOR AND A MAINS INLET CONTAINING AN ARCED FUSE WAS REPLACED. THER WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388765 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1