BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1210047 · Received October 21, 2008

    Report

    Report Number
    1218950-2008-00560
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Report Date
    September 25, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE SHOCK BUTTON WAS NOT WORKING. THE DEVICE WAS EVALUATED BY PHILLIPS. AND THE REPORTED SYMPTOMS WAS DUPLICATED. THE SHOCK BUTTON INSERT WAS REPLACED. THIS RESOLVED THE SYMPTOM, AND THE DEVICE PASSED ALL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SHOCK BUTTON WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX DEFIBRILLATOR LDD PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1