BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1961468 · Received January 9, 2011

    Report

    Report Number
    1218950-2011-00059
    Event Type
    Malfunction
    Date Received
    January 9, 2011
    Report Date
    December 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE UNIT LOCKS UP AND REBOOTS ON ITS OWN. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND THE FAILURE WAS VERIFIED. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT LOCKS UP AND REBOOTS ON ITS OWN. THERE WAS NO REPORT OF 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