BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1953904 · Received December 15, 2010

    Report

    Report Number
    1218950-2010-02606
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Report Date
    November 18, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED GETTING A DEFIB FAILURE CYCLE POWER ERROR 1000 MESSAGE. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND THE FAILURE WAS VERIFIED. THE POWER PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A DEFIB FAILURE CYCLE POWER ERROR 1000 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