BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIIC IX HARDWARE

    MDR report key: 10167472 · Received June 18, 2020

    Report

    Report Number
    1218950-2020-03539
    Event Type
    Death
    Date Received
    June 18, 2020
    Report Date
    June 10, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838052130
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PHILIPS RESPONSE CENTER ENGINEER (RCE), WHO INDICATED THAT THE CUSTOMER SEARCHED FOR PATIENT TREND DATA AND DID NOT FIND CORRECT DATA BECAUSE A WRONG NAME HAD BEEN CHOSEN. THE RCE ALSO INDICATED THAT THE PATIENT DEATH HAS NOTHING TO DO WITH THE PHILIPS DEVICE. THE CUSTOMER ALSO WOULD LIKE TO KNOW IF OUR DATA COULD BE SAVED DIGITALLY. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE, AS A WRONG NAME HAD BEEN CHOSEN, WHEN THE CUSTOMER SEARCHED FOR PATIENT TREND DATA. INFORMATION WAS PROVIDED TO THE CUSTOMER INDICATING THAT DATA IS STORED LOCALLY AT FOR 7 DAYS, AND THERE ARE NO OPTIONS FOR DIGITAL DATA EXPORT. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT DATA WAS NOT SAVED. THE PATIENT DIED, AFTER DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632432 PIIC IX HARDWARE CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866424 00884838052130

    Patients

    Seq Age Sex Outcome Treatment
    1 Death