BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 6504091 · Received April 19, 2017

    Report

    Report Number
    1218950-2017-02534
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Report Date
    March 28, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ONE PROCESSOR PCA WAS RETURNED FOR FAILURE ANALYSIS. THE REPORTED PROBLEM WAS VERIFIED / DUPLICATED DURING LAB TESTS. THE SOM PCA WAS FOUND TO BE CORRUPT. THE AVAILABLE INFORMATION IS CONSISTENT WITH A MALFUNCTION OF THE PROCESSOR PCA. THE CAUSE WAS A CORRUPT SOM PCA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT "CANNOT ENTER SYSTEM". THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284577 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1