BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1905598 · Received November 11, 2010

    Report

    Report Number
    1218950-2010-02250
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Report Date
    October 15, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT READ THE RHYTHM (ECG) VIA THE PADS HANDS FREE CABLE. THERE WAS NO REPORT OF ADVERSE PT IMPACT. PHILIPS EVALUATED THE DEVICE, CONFIRMED THE FAILURE, AND RESOLVED THE FAILURE BY REPLACING THE PADS HANDS FREE CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT READ THE RHYTHM (ECG) VIA THE PADS HANDS FREE CABLE. THERE WAS NO REPORT OF ADVERSE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1