BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3108535 · Received April 15, 2013

    Report

    Report Number
    3108535
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 12, 2013
    Manufacturer
    PHILIPS HEALTHCARE INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT MALFUNCTIONED AND DID NOT SHOCK PATIENT AS EXPECTED. THERE WAS A PROBLEM WITH THE PAD STICKING TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TO SHOCK THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161571 HEARTSTART MRX AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHILIPS HEALTHCARE INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR