BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2223227 · Received August 16, 2011

    Report

    Report Number
    1218950-2011-02401
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A USER INITIATED EXTENDED SELF TEST, DEFIB TEST FAILURE. THE LOCAL PHILIPS REPRESENTATIVE CONFIRMED THIS CONDITION AND REPORTED THAT THE DEVICE WOULD NOT CHARGE ENERGY FOR THE DEFIB TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A USER INITIATED EXTENDED SELF TEST, DEFIB TEST FAILURE. THE LOCAL PHILIPS REPRESENTATIVE CONFIRMED THIS CONDITION AND REPORTED THAT THE DEVICE WOULD NOT CHARGE ENERGY FOR THE DEFIB TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1