BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2041322 · Received March 9, 2011

    Report

    Report Number
    1218950-2011-00618
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 8, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SHOCK AS EXPECTED IN THE SYNC MODE. THERE WAS NO REPORT OF NEGATIVE PT IMPACT. PHILIPS EVALUATED THE DEVICE AND THERE WAS NO MALFUNCTION. THE DEVICE PASSED ALL STANDARD TESTING. PHILIPS REVIEWED THE ECG STRIP THAT WAS PROVIDED FOR REVIEW. THE STRIP SHOWED THAT THE REPRESENTATIVE ECG WAVEFORM DID NOT MEET THE CRITERIA FOR R-WAVE MARKERS TO BE PLACED. INFO WAS PROVIDED TO THE USERS REGARDING LEAD SELECTION AND R-WAVE MARKERS. THIS WAS A USER MISUNDERSTANDING RELATED TO ECG LEAD SELECTION AND NOT A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SHOCK AS EXPECTED IN THE SYNC MODE. THERE WAS NO REPORT OF NEGATIVE 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