BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL

    MDR report key: 12770107 · Received November 8, 2021

    Report

    Report Number
    12770107
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 28, 2021
    Report Date
    November 3, 2021
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRE BYPASS NEEDED TO BE CARDIOVERTED WITH EXTERNAL PADS, WHICH WAS SUCCESSFUL. APPROXIMATELY 20 MINUTES LATER PATIENT NEEDED TO BE CARDIOVERTED AGAIN, HOWEVER THE DEFIBRILLATOR NO LONGER HAD EKG TRACING. AT THIS POINT, I MADE SURE ALL CABLES WERE STILL PROPERLY CONNECTED. I SWITCHED TO THE EXTERNAL PAD CABLE AND DID NOT HAVE EKG TRACING STILL. AT THIS POINT, I CALLED FOR A NEW DEFIBRILLATOR. ALL CURRENT CORDS WERE PLUGGED INTO THE NEW DEFIBRILLATOR AND DID NOT GET AN EKG TRACING. THE SYNC CABLE, CABLE THAT ATTACHES TO INTERNAL PADDLES, AND INTERNAL PADDLES WERE ALL SWITCHED OUT AND PLUGGED INTO NEW DEFIBRILLATOR, STILL NO EKG TRACING. DURING THIS TIME THE SURGEON WAS PERFORMING CARDIAC MASSAGE AND ANESTHESIA WAS ADMINISTERING RESUSCITATIVE MEDICATIONS. CLINICAL COORDINATOR, CVOR CHARGE NURSE, EP STAFF MEMBERS, AND BIO MED WERE PRESENT AND TRYING TO ASSIST IN DIAGNOSING THE PROBLEM. PATIENT WAS ABLE TO CONVERT OUT OF RHYTHM AS WE WERE STILL UNSUCCESSFUL TO CARDIOVERT. AT THE END OF THE CASE THE SYNCH CABLES, R2 PADS, AND DEFIBRILLATORS WERE TAKEN BY BIO MED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668878 ZOLL AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 1095 DA Male