BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ADULT MULTIFUNCTION PADS PLUS

    MDR report key: 3071085 · Received April 8, 2013

    Report

    Report Number
    1218950-2013-01291
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K002806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED TO DISCHARGE USING PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142669 HEARTSTART ADULT MULTIFUNCTION PADS PLUS MKJ PHILIPS MEDICAL SYSTEMS M3713A 111312-01

    Patients

    Seq Age Sex Outcome Treatment
    1