BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 9859735 · Received March 20, 2020

    Report

    Report Number
    9859735
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 3, 2020
    Manufacturer
    PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CARDIAC SURGEON USED THE INTERNAL DEFIB PADDLES DURING OUR CASE TO GET OUR PATIENT BACK INTO A PERFUSING RHYTHM. PADDLES WERE PUT AWAY. PATIENT WAS BLEEDING AND WE USED SUCTION IN THE PERICARDIUM. WHILE SUCKING OUT THE PERICARDIUM, THE CARDIAC SURGEON PULLED OUT FROM BEHIND THE HEART WHAT LOOKED LIKE A PIECE OF SHARP PLASTIC. AFTER FURTHER INVESTIGATION, WE MATCHED THAT SHARP PIECE TO PART OF OUR INTERNAL DEFIB PADDLES. PIECE HANDED OFF THE FIELD, A "REPAIR" TAG WAS PLACED ON THE PADDLES AND TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324645 HEARTSTART XL AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHILIPS ELECTRONICS NORTH AMERICA CORPORATION M4742A

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA