BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX, BIPHASIC

    MDR report key: 611231 · Received June 1, 2005

    Report

    Report Number
    611231
    Event Type
    Death
    Date Received
    June 1, 2005
    Date of Event
    May 9, 2005
    Report Date
    June 1, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PACEMAKER NOT GOING TO PACEMAKER MODE. DURING A CODE, MD WANTED TO TRY AND PACE THE PATIENT IN ASYSTOLE. PACER PADS WERE APPLIED IN THE PROPER POSITION AND HOOKED UP TO THE BIPHASIC MACHINE. PATIENT WAS SHOCKED THREE TIMES DURING THE CODE WITHOUT SUCCESS. WHEN THE PACER MODE WAS SELECTED, THE MONITOR SCREEN LOST THE ASYSTOLE TRACING AND READ A DOTTED LINE. THE MACHINE WOULD ONLY READ TO APPLY PATCHES. CAPTURE WAS UNABLE TO BE OBTAINED FROM 20 TO 100 - AFTER REATTACHING THE PACER PADS TO THE CONNECTOR AND THE CABLE TO THE BIPHASIC. AGAIN, PROCESS WAS REPEATED WITH THE SAME RESULT. THIS PROCESS WAS REPEATED FOUR TIMES BEFORE THE CODE WAS CALLED BY THE DOCTOR. AFTER THE CODE, READ THE MANUAL TO SEE IF SOMETHING WAS DONE WRONG. UNABLE TO DETERMINE.

    Description of Event or Problem · 1

    THE HOSPITAL'S BIOMEDICAL ENGINEER INITIALLY CONTACTED PHILLIPS MEDICAL SYSTEMS INDICATING THAT THE DEVICE FAILED A PACING TEST AND THAT THE DEVICE WOULD NOT RECOGNIZE THE (DEFIBRILLATION) PADS. SUBSEQUENT DISCUSSION WITH NURSING STAFF INDICATED THAT A PT WAS INVOLVED AND THAT THE FAILURE OCCURRED DURING CLINICAL USE OF THE DEVICE. LIMITED INFORMATION WAS PROVIDED INDICATING THAT THERE WAS DIFFICULTY PACING A PATIENT DURING A RESUSCITATION ATTEMPT. THE PT SUBSEQUENTLY EXPIRED, WHICH THE STAFF DID NOT ATTRIBUTE TO THE DEVICE. THE DEVICE WAS NOT RETURNED TO PHILIPS MEDICAL SYSTEMS FOR EVALUATION. HOWEVER, THE EVENT SUMMARY REPORT AND DATA CARD, WHICH LOGS EVENTS AND DEVICE INFORMATION, WERE RETURNED FOR EVALUATION. REVIEW OF THE EVENT SUMMARY REPORT INDICATED THAT THE DEVICE WAS INITIALLY TURNED ON IN PACER MODE AND LEAD II WAS SELECTED. THERE WAS AN ASYSTOLE MESSAGE, FOLLOWED BY THE DELIVERY OF THREE DEFIBRILLATION SHOCKS. PACER MODE WAS SELECTED AGAIN, BUT THE DEVICE WAS SUBSEQUENTLY TURNED OFF. REVIEW OF THE DATA CARD CONFIRMED THE INFORMATION IN THE EVENT SUMMARTY. THE INFORMATION RECORDED ON THE DATA CARD PROVIDES MORE DETAIL THAN THE EVENT SUMMARY. THIS INFORMATION INDICATED THAT ALTHOUGH THE USER DID SELECT THE PACING MODE OF OPERATION AT THREE SEPARATE TIMES, THEY DID NOT INITIATE PACING. PACING IS INITIATED BY PRESSING THE "START PACING" BUTTON WHEN IN THE PACING MODE OF OPERATION. IN REGARD TO THE REPORT THAT THE DEVICE WOULD NOT RECOGNIZE THE PADS, THE INFORMATION CONTAINED IN THE DATA CARD INDICATED THAT, WHEN THE DEVICE WAS INITIALLY TURNED ON IN THE PACING MODE, ONLY THE ECG ELECTRODES WERE APPLIED. THE PADS WERE NOT APPLIED TO THE PT UNTIL THE BEGINNING OF THE DEFIBRILLATION THERAPY. FOLLOWING THE DEFIBRILLATION THERAPY, THERE WERE INTERMITTENT LEADS OFF AS INDICTED BY THE DOTTED LINE WHILE ATTEMPTING TO INITIATE PACING THERAPY. AS PREVIOUSLY INDICATED, PACING WAS NEVER INITIATED BY THE USER. IF PACING HAD BEEN PROPERLY INITIATED, THE USER WOULD HAVE BEEN ALERTED TO THE SOURCE OF THE LEADS OFF CONDITION. RESULTING FROM OUR REVIEW OF THE EVENT SUMMARY REPORT AND DATA CARD, WE HAVE CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION. THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT (INABILITY TO PACE) IS THE RESULT OF THE "START PACING" BUTTON NOT BEING PRESSED. THE HOSPITAL REPORTED TO PHILIPS MEDICAL SYSTEMS THAT THE EVENT OCCURRED ON MAY 9, 2005. PHILIIPS MEDICAL SYSTEMS RECEIVED INFORMATION FROM THE HOSPITAL ABOUT THIS EVENT ON MAY 9, 2005. THE DEVICE WAS NOT RETURNED TO PHILIPS MEDICAL SYSTEMS. TO THE BEST OF OUR KNOWLEDGE, THE DEVICE IS AT THE HOSPITAL AND IS AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX, BIPHASIC DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death