BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 13572951 · Received February 21, 2022

    Report

    Report Number
    3030677-2022-01003
    Event Type
    Death
    Date Received
    February 21, 2022
    Date of Event
    January 20, 2022
    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
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO PHILIPS THAT A PATIENT WAS PRE-ALERTED DUE TO THEM BEING IN A PERI-ARREST STATE. CRITICAL CARE AMBULANCE CREW HANDED OVER THE PATIENT WHO WAS BRADYCARDIC WITH A VERY POOR, SOMETIMES UNPALPABLE PULSE. DUE TO THE NATURE OF THE INCIDENT THE PATIENT WAS BEING PACED BY THE AIR AMBULANCE CREW OF 80BPM AT 150MA. THE AIR AMBULANCE CREW SWAPPED ALL OF THE EQUIPMENT WITH THE CUSTOMER'S. ONCE CONNECTED THERE WAS NO READING ON THE SCREEN. THE LEADS WERE NOT GETTING A READING. CUSTOMER THEN SWAPPED BACK TO THE AIR AMBULANCE CREW LEADS. THAT MACHINE WAS RECEIVING A READING BUT THERE WAS NO PALPABLE PULSE AT THIS POINT. CPR WAS COMMENCED AND IT WAS NOW A CARDIAC ARREST. A NEW SET OF DEFIB PADS WERE PLACED ON THE PATIENT AND CUSTOMER WAS GETTING A READING ON THE DEFIBRILLATOR BUT THROUGH PADS ONLY. THE PATIENT OUTCOME WAS DEATH. THE CUSTOMER EVALUATED THE DEVICE FOLLOWING THE EVENT AND FOUND THAT THE LEADS ECG FUNCTION AND ECG CABLE FAILED DURING AN OP CHECK. THE DEVICE WAS NOT EVALUATED BY PHILIPS. A PHILIPS CLINICIAN REVIEWED THE PROVIDED EVENT FILE. LEAD II SELECTED AS ECG SOURCE AT START OF EVENT, NO ECG TRACING PRESENT. AT ET (ELAPSED TIME) 00:01:13, PADS ON MESSAGE IS SEEN, LEAD CHANGE TO PADS, AND ECG TRACING BEGINS. AT ET 00:01:17, LEAD CHANGE TO II, NO ECG TRACING PRESENT AND PACER MODE SELECTED. AT ET 00:01:19, ECG WAS UNPLUGGED. AT ET 00:02:16, PACER MODE WAS SELECTED, IMMEDIATELY FOLLOWED BY A PADS OFF MESSAGE. AT ET 00:05:47, LEADS ON WAS SEEN, LEAD CHANGE TO II, AND ECG TRACING WITH ARTIFACT/NOISY ECG MESSAGE. AT ET 00:06:03, THERE WAS AN ASYSTOLE ALARM AND ECG TRACING REMAINS. AT ET 00:06:06, THERE WAS A LEADS OFF MESSAGE WITH NO ECG TRACING PRESENT. AT ET 00:06:21, PADS ON IS SEEN, HOWEVER LEAD CHANGED TO III, WITH NO ECG TRACING PRESENT. AT ET 00:06:42, THERE WAS LEAD CHANGE TO PADS, ECG TRACING APPEARS, HR 133BPM NOTED (TOO FAST TO TRIGGER ICD OR DEMAND MODE TRANSCUTANEOUS PACING). AT ET 00:07:04, PADS ECG WAS STILL SELECTED, ECG TRACING APPEARS, AND PACING SPIKES BEGIN TO APPEAR INTERMITTENTLY. AT ET 00:17:23, PACER MODE WAS SELECTED, LEAD CHANGE TO II, WITH NO ECG TRACING PRESENT. AT ET 00:18:49, PACER MODE WAS SELECTED, WITH NO ECG TRACING PRESENT UNTIL SWITCHING TO PADS AS THE ECG SOURCE. ALTHOUGH THE CUSTOMER EVALUATED THE DEVICE, ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON THE RESOLUTION OF THE REPORTED MALFUNCTION WENT UNANSWERED BY THE CUSTOMER. FOLLOWING THE CLINICAL EVENT REVIEW IT WAS FOUND THAT DURING THE EVENT, EACH TIME THE ECG SOURCE WAS SELECTED FROM LEADS, NO ECG TRACING WAS CAPTURED. THE HEARTSTART MRX INSTRUCTIONS FOR USE (PUBLICATION 453564307761, PAGE 90) STATES: ¿THE HEARTSTART MRX REQUIRES A 3-, 5-, OR 10-LEAD ECG CABLE AND MONITORING ELECTRODES AS THE SOURCE OF THE ECG DURING DEMAND PACING. PACE PULSES ARE DELIVERED THROUGH THE MULTIFUNCTION ELECTRODE PADS.¿ AS HIGHLIGHTED IN THE INSTRUCTIONS FOR USE, PACER MODE REQUIRES LEADS ECG AS THE SOURCE OF THE ECG DURING DEMAND PACING. AS LEADS ECG WAS NOT FUNCTIONAL, PACING COULD NOT BE STARTED, DESPITE SWITCHING THE DEVICE INTO PACER MODE. ALSO PRESENT DURING THE EVENT WERE PACER SPIKES, WHICH COULD HAVE BEEN GENERATED BY THE AIR AMBULANCE DEVICE PLACED BACK ONTO THE PATIENT AFTER THE MRX PACING FAILURE, OR AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) IF THE PATIENT HAD SUCH A DEVICE IMPLANTED. THROUGHOUT THE EVENT, ONLY PADS ECG WAS ABLE TO CAPTURE THE PATIENT¿S CARDIAC ACTIVITY. PHILIPS IS UNABLE TO RULE OUT THAT A MALFUNCTION DID NOT OCCUR. AS ADDITIONAL INFORMATION IS UNAVAILABLE, A DEFINITIVE CAUSE FOR THE ALLEGED FAILURE COULD NOT BE DETERMINED. THE AVAILABLE INFORMATION FROM THIS REPORT DOES NOT SUPPORT THAT THIS MALFUNCTION REPRESENTS A SYSTEMIC, DESIGN, OR LABELING PROBLEM. NO ADDITIONAL INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE PATIENT WAS PRE-ALERTED DUE TO THEM BEING IN A PERRI-ARREST STATE. CRITICAL CARE AMBULANCE CREW HANDED OVER THE PATIENT WHO WAS BRADYCARDIC WITH A VERY POOR, SOMETIMES UNPALPABLE PULSE. DUE TO THE NATURE OF THE INCIDENT THE PATIENT WAS BEING PACED BY THE AIR AMBULANCE CREW OF 80BPM AT 150MA. THEIR EQUIPMENT IS NOT COMPATIBLE WITH QEH. OUR DEFIBRILLATOR AND LEADS WERE READY TO BE PUT ON SO WE SWAPPED ALL THEIR PACING EQUIPMENT WITH OURS. ONCE CONNECTED THERE WAS NO READING ON THE SCREEN. IT SEEMED THE LEADS WERE NOT WORKING. WE SWAPPED BACK TO THE AIR AMBULANCE CREW LEADS. THEIR MACHINE WAS RECEIVING A READING BUT THERE WAS NO PALPABLE PULSE AT THIS POINT. CPR WAS COMMENCED AND IT WAS NOW A CARDIAC ARREST. A NEW SET OF DEFIB PADS WERE PLACED ON THE PATIENT AND WE WERE GETTING A READING ON OUR DEFIBRILLATOR BUT THROUGH PADS ONLY. THERE IS NO ABILITY TO CONFIRM IF THE DEFIB HAD NOT BEEN FAULTY AND PACING HAD NOT BEEN INTERRUPTED WHETHER THE PATIENT WOULD HAVE HAD A CARDIAC ARREST. ONCE THERE WAS NO PALPABLE PULSE, CPR WAS COMMENCED WHILE RECONNECTION OF DEFIB PADS WAS BEING CARRIED OUT. AN ADDITIONAL DEFIBRILLATOR WITHIN THE DEPARTMENT WAS RETRIEVED AND WAS USED INSTEAD. A MANUAL TEST WAS CARRIED OUT ON THE FAULTY DEFIB AFTER THE INCIDENT AND FAILED SO IT WAS TAKEN TO EBME FOR TESTING. THE DEFIBRILLATOR HAS BEEN IMPOUNDED BY EBME PENDING INVESTIGATION BY MHRA / PHILIPS HEALTHCARE. THE EVENT LOG HAS BEEN DOWNLOADED BY THE RESUSCITATION OFFICER. THE DEFIBRILLATOR HAS NOT BEEN CHECKED TO ASCERTAIN WHETHER IT IS FAULTY OR NOT; THIS WILL BE REFERRED TO THE MHRA FOR THEIR GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65434 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death