BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 11721237 · Received April 23, 2021

    Report

    Report Number
    3030677-2021-11192
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    April 20, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A PHILIPS CLINICIAN REVIEWED THE PATIENT EVENT FILE. ON 20APR2021, THE HEARTSTART MRX WAS POWERED ON INTO THE MANUAL MODE FOR USE ON A 4 YEAR OLD PATIENT. THE USERS SELECTED A 50J SETTING; DEFIBRILLATOR PADS AND ECG MONITORING LEADS WERE PLACED, AND THE SYNC MODE WAS SELECTED. AT 5:13 ELAPSED TIME (ET), THE USERS CHARGED THE 50J ENERGY BUT THE ENERGY WAS NOT DELIVERED. THERE WERE SEVERAL PADS OFF/ON AND LEADS OFF/ON MESSAGES THAT FOLLOWED. AT 6:22 ET, THE USERS CHARGED TO 50J AGAIN AND AT 6:28 ET THE SYNC SHOCK WAS DELIVERED. AT THE TIME OF THE FIRST ATTEMPTED SYNC SHOCK, THE RHYTHM HAD A NARROW COMPLEX, IRREGULAR WAVEFORM, THAT WAS BIPHASIC (ABOVE AND BELOW THE BASELINE). THE RATE WAS APPROXIMATELY 70 BEATS PER MINUTE. INTERMITTENT NARROW SPIKES ARE SEEN IN THE WAVEFORM THAT ARE CONSISTENT WITH ARTIFACT. AS R-WAVE MARKERS ARE NOT STORED RETROSPECTIVELY AND THEREFORE CANNOT BE VIEWED, AND GIVEN THE BIPHASIC APPEARANCE OF THE ECG WAVEFORM, THE INABILITY TO DELIVER THE SHOCK MAY BE RELATED TO INTERMITTENT OR INCONSISTENT DETECTION OF THE R-WAVE (REQUIRED FOR A SYNC SHOCK). THE HEARTSTART MRX INSTRUCTIONS FOR USE (IFU - PUBLICATION 453564307761 - PAGE 84) PROVIDES THE USER INFORMATION ON HOW TO SELECT THE BEST LEAD FOR ECG MONITORING AND R-WAVE DETECTION. THE IFU STATES "CONFIRM THAT THE SYNC MARKER APPEARS ONLY WITH EACH R-WAVE. R-WAVE MARKERS DO NOT ALWAYS APPEAR AT THE PEAK OF THE R-WAVE BUT ALWAYS APPEAR ON THE R-WAVE. USE THE LEAD SELECT BUTTON TO CHANGE LEADS IF THE R-WAVE MARKERS DO NOT APPEAR CORRECTLY." A PHILIPS REPAIR BENCH TECHNICIAN 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. PHILIPS IS UNABLE TO CONFIRM THE CAUSE OF THE REPORTED SYMPTOM. HOWEVER, THE DEVICE PASSED ALL TESTING AND THE APPEARANCE OF THE WAVEFORM IS BIPHASIC. THEREFORE, THE R-WAVE DETECTION MAY HAVE BEEN INCONSISTENT IMPACTING THE ABILITY TO DELIVER ENERGY.

    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 CLINICAL USER WAS PREPARING TO DEFIBRILLATE THEIR PATIENT BUT INADVERTENTLY SELECTED THE SYNCHRONIZED CARDIOVERSION (SYNC) BUTTON INSTEAD OF PERFORMING MANUAL DEFIBRILLATION. THE USER FAILED TO DELIVER A SHOCK TO THE PATIENT. THE USER REPLACED THE HEARTSTART MRX AND THE REPLACEMENT DEFIBRILLATOR DELIVERED THE SHOCK TO THE PATIENT. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY REQUIRING ANOTHER DEVICE TO CONTINUE TREATMENT AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616030 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Life Threatening