BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT DATA MODULE

    MDR report key: 3102429 · Received May 1, 2013

    Report

    Report Number
    2124823-2013-00015
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K071073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEIR PT DATA MODULE (PDM) HAD AN ISSUE WITH THE SPRING RELEASE TAB, RESULTING IN THE PDM NOT LOCKING PROPERLY. THE CUSTOMER REPORTED THE PDM FELL OUT AND HIT THE PT'S SHOULDER. THE PT DID NOT REQUIRE MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190686 PATIENT DATA MODULE PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1