BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2051344 · Received April 4, 2011

    Report

    Report Number
    1218950-2011-00882
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Report Date
    March 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A CHARGE BUTTON FAILURE AND A BEEPING NOISE. THERE WAS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED AND THE FIELD SVC ENGINEER VERIFIED THE CHARGE BUTTON FAILURE MESSAGE. THE ISSUE WAS RESOLVED BY RELOADING THE SOFTWARE AND REBOOTING THE DEVICE. WE ARE CONSIDERING THIS A MALFUNCTION RESULTING FROM CORRUPT SOFTWARE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CHARGE BUTTON FAILURE AND A BEEPING NOISE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1