BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1913505 · Received November 24, 2010

    Report

    Report Number
    1218950-2010-02387
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    November 2, 2010
    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 THAT THIS UNIT HAD A RED X AND THE SCREEN MESSAGE "ECG FRONT END FAILURE". THE UNIT WAS EVALUATED LOCALLY BY A PHILIPS FIELD SERVICE ENGINEER, AND THE FAILURE WAS VERIFIED. REPLACING THE POWER PCA RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS UNIT HAD A RED X AND THE SCREEN MESSAGE "ECG FRONT END FAILURE".

    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