BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIIC IX UPGRADE FROM PIIC

    MDR report key: 7195978 · Received January 16, 2018

    Report

    Report Number
    1218950-2018-00522
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Report Date
    January 2, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FCO (B)(4) FCO (B)(4) FCO (B)(4) .

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE PHILIPS INTELLIVUE INFORMATION CENTER (PIIC) IX REBOOTS WHILE ATTEMPTING TO DISCHARGE A PATIENT. THIS ISSUE CAN ONLY OCCUR WHEN THE PIIC IX SYSTEM DATE IS (B)(6) 2018 OR LATER. NO ADVERSE PATIENT EFFECTS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41357 PIIC IX UPGRADE FROM PIIC CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866117

    Patients

    Seq Age Sex Outcome Treatment
    1