BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 8211999 · Received January 3, 2019

    Report

    Report Number
    1218950-2019-00054
    Event Type
    Death
    Date Received
    January 3, 2019
    Date of Event
    December 17, 2018
    Report Date
    December 13, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE HAD TROUBLE OBTAINING A QUALITY ECG AND WAS ONLY ABLE TO VISUALIZE V3 WHEN ATTEMPTING 12 ECG ACQUISITION. THE CUSTOMER SWITCHED TO PADS MONITORING AND WAS ABLE TO OBTAIN AN ECG. THE DEVICE WAS EVENTUALLY USED TO SHOCK THE PATIENT BUT THE PATIENT EVENTUALLY DIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE HAD TROUBLE OBTAINING A QUALITY ECG AND WAS ONLY ABLE TO VISUALIZE V3 WHEN ATTEMPTING 12 ECG ACQUISITION. THE CUSTOMER SWITCHED TO PADS MONITORING AND WAS ABLE TO OBTAIN AN ECG. THE DEVICE WAS EVENTUALLY USED TO SHOCK THE PATIENT BUT THE PATIENT EVENTUALLY DIED. THIS REPORTER STATED THAT AN (B)(6) YEARS OLD FEMALE PATIENT EXPERIENCED AN EVENT NOT REPORTED ON (B)(6) 2018. DURING THE EVENT, EMERGENCY MEDICAL SERVICES ARRIVED ON SCENE AND CONNECTED THE PATIENT TO A HEARTSTART MRX DEVICE VIA ECG ELECTRODES AND DEFIBRILLATOR PADS. NO RELEVANT MEDICAL HISTORY, RELEVANT PAST DRUG HISTORY OR RELEVANT CONCOMITANT MEDICATION INFORMATION WAS REPORTED. REVIEW OF PROVIDED ELECTROCARDIOGRAM (ECG) RHYTHM STRIPS AND CASE EVENTS SHOWED THE PATIENT¿S INITIAL HEART RHYTHM WAS CONSISTENT WITH A BRADYCARDIC WIDE QRS COMPLEX WITH TALL PEAKED T WAVES AND A HEART RATE OF APPROXIMATELY 48 BEATS PER MINUTE (BPM). THROUGHOUT THE ENTIRE EVENT, THERE WERE SEVERAL ¿CANNOT ANALYZE ECG¿ AND ¿LEADS OFF¿ MESSAGES GENERATED. AT 14:25:32 AND 14:27:46, EPINEPHRINE WAS ADMINISTERED; DOSE AND ROUTE NOT REPORTED. AT 14:33:21, THE PATIENT HAD A HEART RHYTHM CONSISTENT WITH A COARSE VENTRICULAR FIBRILLATION, A ¿SHOCK ADVISED¿ MESSAGE WAS GENERATED, THE DEVICE WAS CHARGED WITH 150 J OF ENERGY, SHOCK ONE WITH 151.1 J OF ENERGY WAS DELIVERED TO THE PATIENT AT 14:33:29, BUT THE RHYTHM DID NOT CONVERT TO A NORMAL SINUS RHYTHM. THERE WAS ONLY ONE SHOCK DELIVERED DURING THE EVENT AND NO 12-LEAD ECG RHYTHM STRIPS WERE GENERATED. NO RELEVANT LABORATORY DATA WAS REPORTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OUTCOME OF DEATH. INOP (TECHNICAL) CONDITIONS INOP CONDITIONS ARE THOSE MOST LIKELY INVOLVING AN EQUIPMENT ISSUE, SUCH AS DETACHED ELECTRODES OR BROKEN LEAD WIRES. A ¿LEAD OFF¿ OR ¿CANNOT ANALYZE ECG¿ CONDITION, WHICH RESULTS IN THE LOSS OF ECG MONITORING, WILL ALSO INHIBIT ARRHYTHMIA MONITORING UNTIL THE CONDITION IS CORRECTED AND THE LEAD HAS BEEN RESTORED. INOP (OR TECHNICAL) ALARMS OCCUR WHENEVER THE ECG SIGNAL CANNOT BE PROPERLY ANALYZED DUE TO NOISE OR INOP (OR TECHNICAL) CONDITIONS. IF MORE THAN 2/3 OF THE TIME OVER THE LAST 30 SECONDS BEATS ARE CLASSIFIED AS EITHER NOISY OR QUESTIONABLE, A CANNOT ANALYZE INOP (OR TECHNICAL) ALARM IS GENERATED. WHEN ACTIVE, THE INOP (OR TECHNICAL) ALARM CONTINUES, VISUALLY AND AUDIBLY, AS LONG AS THE CONDITION EXISTS, AND STOPS AUTOMATICALLY WHEN THE CONDITION TERMINATES (ARRHYTHMIA MONITORING ALGORITHM, APPLICATION NOTE, PUBLICATION NUMBER 453564119641, EDITION 2, AUGUST 2011, PAGES 3 AND 14). THE FSE REPLACED ECG TRUNK CABLE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. PHILIPS IS CONSIDERING THIS TO BE A MALFUNCTION OF THE ECG TRUNK CABLE DUE TO THE FSE FINDING THE WORN ECG TRUNK DURING TROUBLE SHOOTING AND THE CORRELATING ¿LEAD OFF¿ AND ¿CANNOT ANALYZE ECG¿ MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7163 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death