BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2942155 · Received December 28, 2012

    Report

    Report Number
    1218950-2012-04293
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    December 4, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE FAILED TO POWER UP. NO PATIENT INVOLVEMENT WAS REPORTED. A PHILIPS BENCH TECHNICIAN EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE ISSUE WAS DETERMINED TO BE A FAILURE OF THE ENERGY SELECT SWITCH. THE ENERGY SWITCH WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE REMAINS AT THE CUSTOMER'S SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED TO POWER UP. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1