BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 661565 · Received December 27, 2005

    Report

    Report Number
    MW1037476
    Event Type
    Malfunction
    Date Received
    December 27, 2005
    Report Date
    December 27, 2005
    Manufacturer
    NON INVASIVE MEDICAL TECHNOLOGIES
    Product Code
    DSB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE IS USED TO MONITOR FLUID ACCUMULATION IN THE CHEST OF CHF PTS WHO HAVE BEEN IN AND OUT OF THE HOSP ON TWO OR MORE OCCASIONS IN THE LAST SIX MONTHS. A PILOT STUDY WAS DONE AND IT WAS FOUND THAT THE CABLES HAD PROBLEMS. THERE WERE NO READINGS ON THE MACHINE. THREE CABLES WERE REPLACED ON TWO OCCASIONS BUT THERE WERE NO READINGS ON THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ZOE-BIO IMPEDANCE MONITOR DSB NON INVASIVE MEDICAL TECHNOLOGIES * PN 41610/H1117/G1239

    Patients

    Seq Age Sex Outcome Treatment
    1 *