BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIIC IX HARDWARE

    MDR report key: 7464321 · Received April 26, 2018

    Report

    Report Number
    1218950-2018-03715
    Event Type
    Death
    Date Received
    April 26, 2018
    Date of Event
    April 18, 2018
    Report Date
    April 19, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PATIENT INFO HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE), WAS PAGED TO CONTACT THE CUSTOMER. PER THE SAP NOTES, THE FSE SET THE TIME AND UPGRADED THE CUSTOMER TO SOFTWARE REVISION B.02.13. THE SOFTWARE UPGRADE PERFORMED WAS NOT SPECIFIC TO THE REPORTED ISSUE, BUT AS A CUSTOMER SATISFACTION ACTION. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, THERE WAS NO RESPONSE. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN, HOWEVER, IT WILL BE CONSIDERED A MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INACCURATE TIME AT THE CENTRAL STATION AND A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309685 PIIC IX HARDWARE CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866424 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Death