BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEARTSTART XL M4735A

    MDR report key: 587148 · Received March 29, 2005

    Report

    Report Number
    MW1035064
    Event Type
    Malfunction
    Date Received
    March 29, 2005
    Date of Event
    March 28, 2005
    Report Date
    March 29, 2005
    Manufacturer
    PHILIPS ELECTRONICS NORTH AMERICA CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN TRAINING THE DEVICE FUNCTIONED PROPERLY - DEMONSTRATED PT IN VENTRICULAR FIBRILLATION, AED ADVISED SHOCK & BEGAN TO CHARGE. RPTR SIMULATED A CHANGE TO NORMAL SINUS RHYTYM; THE DEVICE CONTINUED TO ADVISE TO SHOCK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, DURING AED TRAINING, THE SIMULATOR WAS SET TO VENTRICULAR FIBRILLATION. AFTER THE DEVICE ADVISED A SHOCK, THE SIMULATOR WAS SET TO NORMAL SINUS RHYTHM AND THE DEVICE CONTINUED TO ADVISE A SHOCK. THE CUSTOMER WANTED TO KNOW WHY THE DEVICE DID NOT ABORT THE SHOCK. THE HEARTSTART XL IS DESIGNED SO THAT, IF WITHIN THE ANALYSIS PERIOD (LESS THAN 4.5 SECS) THE UNIT DETECTS A RHYTHM THAT IS CONSIDERED TO BE SHOCKABLE, IT WILL NOT REANALYZE THAT RHYTHM AUTOMATICALLY WITHIN THE ANALYSIS PERIOD. THE INSTRUCTIONS FOR USE INCLUDES A SECTION OF SAFETY CONSIDERATIONS, WHICH CAUTIONS USERS TO "REMAIN ATTENTIVE TO THE PT DURING THE DELIVERY OF THERAPY. DELAY IN DELIVERING A SHOCK MAY RESULT IN A RHYTHM THAT WAS ANALYZED AS SHOCKABLE CONVERTING SPONTANEOUSLY TO NON-SHOCKABLE AND COULD RESULT IN APPROPRIATE DELIVERY OF A SHOCK." THE PRODUCT PERFORMED AS DESIGNED AND EXPECTED. THE CUSTOMER'S CONCERN REPRESENTS A MISUNDERSTANDING AS TO HOW THE DEVICE ANALYZES AND ADVISES EITHER A SHOCK OR NO SHOCK DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS HEARTSTART XL M4735A DEFIBRILLATOR/MONITOR MKJ PHILIPS ELECTRONICS NORTH AMERICA CORP. M4735A *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other