BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1913746 · Received November 23, 2010

    Report

    Report Number
    1218950-2010-02371
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    October 29, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED GETTING A DEFIB FAILURE CYCLE POWER MESSAGE. THE UNIT WAS EVALUATED AT PHILIPS. THE SYMPTOM COULD NOT BE DUPLICATED, HOWEVER, THE ERROR LOG SHOWED MULTIPLE ERROR 10021 ENTRIES SUPPORTING THE DEFIB FAILURE CYCLE POWER MESSAGE. THE CONTROL PCA WAS REPLACED DUE TO THESE ERRORS. THE DEVICE WAS RETURNED TO THE CUSTOMER AFTER PASSING ALL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A DEFIB FAILURE CYCLE POWER MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1