BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC MONITORS

    MDR report key: 4604081 · Received March 6, 2015

    Report

    Report Number
    MW5041416
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    February 16, 2015
    Report Date
    March 6, 2015
    Manufacturer
    GE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) FULL DISCLOSURE REPORT RUN ON (B)(6) SHOWED THE NBP MEAN AND NBP DIAL REVERSED FOR THE ICU PATIENT FROM (B)(6) 2015 18:00-22:00. THIS WAS IDENTIFIED DURING FULL DISCLOSURE REVIEWS PER (B)(6) FOR PATIENT SAFETY RECOMMENDATION IN RESPONSE TO A REPAIRABLE MEDICAL DEVICE ALERT. THERE WAS NO PATIENT INJURY HOWEVER THIS SOFTWARE GLITCH COULD AFFECT FUTURE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156207 CIC MONITORS CENTRAL STATION MONITOR MHX GE CIC

    Patients

    Seq Age Sex Outcome Treatment
    1