BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL + DEFIBRILLATOR/MONITOR

    MDR report key: 3043395 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00839
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE MAINS AC VOLTAGE WAS NOT PRESENT. NO PATIENT INVOLVEMENT WAS REPORTED. 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 THE MAINS AC VOLTAGE WAS NOT PRESENT. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102713 HEARTSTART XL + DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1