BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2230951 · Received July 21, 2011

    Report

    Report Number
    1218950-2011-02099
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 28, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT DURING TESTING, A FAULTY PADS ERROR MESSAGE WAS NOTED. THERE WAS NO PT INVOLVEMENT. PHILIPS SPOKE WITH THE CUSTOMER, WHO EVALUATED THE DEVICE. THE REPORTED SYMPTOM WAS NOT REPRODUCED. THE DEVICE AND PADDLE SET PASSED OP CHECK AND ALL TESTING AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING TESTING, A FAULTY PADS ERROR MESSAGE WAS NOTED. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1