BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 11888691 · Received May 26, 2021

    Report

    Report Number
    3030677-2021-11763
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    May 13, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS CLINICIAN REVIEWED THE PROVIDED PATIENT EVENT FILE. IT WAS FOUND THAT THE XL+ WAS POWERED ON IN MONITOR MODE AND PADS WERE APPLIED TO THE PATIENT. THE ECG WAS VENTRICULAR FIBRILLATION. THE DEVICE WAS PLACED INTO MANUAL MODE AT THE 150J ENERGY SETTING AND CHARGED TO 150J. A DEFIBRILLATION SHOCK WAS DELIVERED ELEVEN SECONDS LATER WHICH INITIALLY CONVERTED THE ECG RHYTHM TO ASYSTOLE, FOLLOWED SEVERAL SECONDS LATER BY A NARROW COMPLEX TACHYCARDIA. THE XL+ WAS POWERED OFF THREE AND ONE HALF MINUTES LATER. NO FURTHER INFORMATION WAS AVAILABLE. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE ISSUE. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. BASED ON THE DEVICE FILE PROVIDED FOR REVIEW, IT WAS NOT POSSIBLE TO DETERMINE HOW THE DEFIBRILLATION SHOCKS WERE INITIATED. THERE WAS NO LONG LAG TIME OR DELAY IN SHOCK DELIVERY FROM THE TIME THEY WERE CHARGED. THE SHOCK WAS DELIVERED ELEVEN SECONDS AFTER IT WAS CHARGED.

    Description of Event or Problem · 0

    [UPDATED] IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS CONNECTED WITH PHILIPS DEFIBRILLATION PADS TO A PATIENT DURING CARDIAC ARREST. THE DEVICE DID SHOCK DELIVERY WITHOUT USER INTERACTION. NO USER GOT CURRENT INTO THEIR BODY. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. THE PATIENT SUDDENLY BECAME UNCONSCIOUS AND STAFF STARTED CPR IMMEDIATELY. THE NURSE PLACED DEFIBRILLATOR ELECTRODES DURING ONGOING CPR AND CONNECTED THE DEFIBRILLATOR PADS TO THE PADS CABLE AND TURNED ON THE DEFIBRILLATOR IN MANUAL MODE 150J WITH SYNC OFF. THE RHYTHM CURVE SHOWED VENTRICULAR TACHYCARDIA. THE NURSE PRESSED ¿CHARGE¿ AND THEN THE DEFIBRILLATION BUTTON. ALL STAFF WERE BACKING AWAY. ANOTHER NURSE THEN BEGINS, PERHAPS AFTER ABOUT 3 SECONDS, AGAIN WITH CARDIAC COMPRESSIONS. THE NURSE IS DOING ABOUT 1-2 COMPRESSIONS. SUDDENLY THE NURSE, WHO DOES THE COMPRESSIONS, THROW HERSELF BACKWARDS AND SCREAMS OF PAIN. SHE RECEIVED ELECTRICITY IN HER HANDS. THERE HAD BEEN A FEW SECONDS SINCE THE RESPONSIBLE NURSE PRESSED THE DEFIBRILLATION BUTTON. THE PATIENT THEN WOKE UP AND, REGAINED SINUS RHYTHM. THE NURSE WHO RECEIVED THE ELECTRICITY WAS WELL.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS CONNECTED WITH PHILIPS DEFIBRILLATION PADS TO A PATIENT DURING CARDIAC ARREST. THE DEVICE DID SHOCK DELIVERY WITHOUT USER INTERACTION. NO USER GOT CURRENT INTO THEIR BODY. ADDITIONAL DETAILS HAVE BEEN REQUESTED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784667 HEARTSTART XL+ DEFIBRILLATOR/MONITOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention