BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1854505 · Received September 30, 2010

    Report

    Report Number
    1218950-2010-01758
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Report Date
    July 22, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED GETTING AN ECG FAULT MESSAGE. ON (B)(6) 2010 THE UNIT WAS EVALUATED BY PHILIPS. THE SYMPTOM WAS VERIFIED. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE. WE ARE CONSIDERING THIS A PROCESSOR PCA MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING AN ECG FAULT MESSAGE.

    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