BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3090217 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01407
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 26, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND THE SYMPTOM WAS VERIFIED. THE ISSUE WAS LOCALIZED TO A FILED ENERGY SELECT SWITCH. THE ENERGY SELECT SWITCH WAS REPLACED. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169516 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1