BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3815301 · Received April 24, 2014

    Report

    Report Number
    1218950-2014-02286
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    March 26, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ECG CONNECTOR WAS WORN AND THAT THERE WAS INTERMITTENT LOSS OF CONTACT WITH THE TRUNK CABLE. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248521 HEARTSTART MRX MJK PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1