BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX- EMS DEFIB

    MDR report key: 3822966 · Received January 16, 2014

    Report

    Report Number
    1218950-2014-00210
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Report Date
    December 24, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    AN "IMPAIRED FUNCTIONING" HEARTSTART MRX WAS REPORTED TO PHILIPS HEALTHCARE. THE DEVICE WAS NOT IN USE WHEN THE REPORTED ISSUE WAS DETECTED. THERE IS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41988 HEARTSTART MRX- EMS DEFIB MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1