BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 6722045 · Received July 18, 2017

    Report

    Report Number
    1218950-2017-04822
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Report Date
    June 29, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PIIC WAS INTERMITTENTLY LOCKING UP. PER COMMUNICATIONS WITH THE RESPONSE CENTER ENGINEER (RCE), THE SYSTEM WOULD NOT UPDATE. THERE WAS NO PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502611 INFORMATION CENTER NETWORK DATABASE CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS M3155 RP5700

    Patients

    Seq Age Sex Outcome Treatment
    1