BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1913733 · Received November 23, 2010

    Report

    Report Number
    1218950-2010-02369
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    October 29, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED GETTING A RED X WITH CHIRPING, ECG FRONT END FAILURE. THE CUSTOMER DID NOT SEND THE DEVICE TO PHILIPS FOR EVALUATION, BUT THE CUSTOMER ORDERED A POWER PCA TO RESOLVE THE ISSUE. AS OF (B)(6) 2010 THE CUSTOMER HAS NOT CALLED BACK REGARDING THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A RED X WITH CHIRPING, 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