BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEARTSTART XL DEFIBRILLATOR

    MDR report key: 9890782 · Received March 27, 2020

    Report

    Report Number
    3007409280-2020-00045
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 5, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K062233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR AN EVALUATION. INITIAL VISUAL INSPECTION FOUND NO ANOMALIES. TECHNICAL EVALUATION IDENTIFIED A THERAPY PCB MALFUNCTION. THE PHILIPS XL + THERAPY CAPACITOR KIT WAS REPLACED. THE CASE WAS CHECKED FOR DAMAGE. THE CIRCUIT BOARDS WERE INSPECTED. THE DEVICE WAS CALIBRATED. THE DISPLAY, ON/OFF POWER, AND TEMP TEST WERE RUN. ALL TESTS PASSED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE THAT THE CAPACITOR HAD A LOW OUTPUT. IT WAS DETERMINED THAT THIS WAS RELATED TO THE PREVIOUS ORDER, AS THIS WAS A PURCHASE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    REPORTEDLY, POST PURCHASE, THE DEVICE DELIVERED MULTIPLE SHOCKS TO THE PATIENT, BUT WHEN THE REPORT WAS PRINTED, IT STATED THAT NO SHOCKS WERE DELIVERED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354412 PHILIPS HEARTSTART XL DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. FQPH4242

    Patients

    Seq Age Sex Outcome Treatment
    1