BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 1841568 · Received September 17, 2010

    Report

    Report Number
    1218950-2010-01643
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Report Date
    August 18, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT AFTER PLACING DEFIB PADS ON A PT, THE PADS ECG WAVEFORM WAS A SQUARE WAVE OR "CLIPPED". THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR, AND USING THE SAME PADS AND PADS CABLE WERE ABLE TO OBSERVE AND MONITOR THE PT PADS ECG RHYTHM. THERE WAS NO IMPACT TO THE PT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT AFTER PLACING DEFIB PADS ON A PT, THE PADS ECG WAVEFORM WAS A SQUARE WAVE OR "CLIPPED". THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR, AND USING THE SAME PADS AND PADS CABLE WERE ABLE TO OBSERVE AND MONITOR THE PT PADS ECG RHYTHM. THERE WAS NO IMPACT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1