BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 3853412 · Received April 4, 2014

    Report

    Report Number
    8010042-2014-00133
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    PMA / PMN Number
    K023354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFORMATION HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR WAS NOT MAINTAINING THE MINIMUM AMOUNT OF PSI WHEN TURNED ON. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205002 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA