BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL

    MDR report key: 453575 · Received April 9, 2003

    Report

    Report Number
    MW1028106
    Event Type
    Injury
    Date Received
    April 9, 2003
    Date of Event
    February 25, 2003
    Report Date
    March 7, 2003
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 08/25/03: THE COMPLAINANT ALLEGED THAT CLINICIANS WERE ATTEMPTING TO DEFIBRILLATE A PT, DURING OPEN HEART SURGERY BUT THE DEVICE WOULD NOT DISCHARGE THE ENERGY FROM THE ASSOCIATED DEFIBRILLATOR. THE CLINICIANS NOTICED THE 'SHOCK' BUTTON ON THE DEFIBRILLATOR WAS ILLUMINATED, INDICATING THAT THE CHARGE HAD ACHIEVED THE 'READY STATE' AND DEPRESSED THE 'SHOCK" BUTTON AND SUCCESSFULLY ADMINISTERED A 30 JOULES SHOCK TO THE PT AND CONVERTED THE HEART-RHYTHM. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT AS A RESULT OF THE MALFUNCTION. AT THIS TIME, THE DEVICE HAS STILL NOT BEEN RECEIVED FOR EVALUATION. THE CUSTOMER HAS BEEN CONTACTED IN AN ATTEMPT TO OBTAIN THE DEVICE AND EFFORTS ARE BEING MADE TO LOCATE THE DEVICE FOR ANALYSIS. SUBSEQUENT TO THE EVENT, THE ASSOCIATED DEFIBRILLATOR, M-SERIES DEFIBRILLATOR/MONITOR/PACEMAKER FROM THE EVENT WAS RECEIVED FOR MAINTENANCE AND AFTER EXTENSIVE TESTING, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND THEN RETURNED TO THE CUSTOMER. IT WAS REPORTED THAT THE CLINICIANS NOTICED THAT THE 'SHOCK' BOTTON ON THE ASSOCIATED DEFIBRILLATOR, WAS ILLUMINATED, INDICATING A 'CHARGE READY" STATE. THE M-SERIES PRODUCTS MAINTAIN A UNIQUE SET OF USER FEEDBACK INDICATORS, WHICH ASSIST USERS TO DETERMINE CORRECTIONS FOR DEVICES-TO-PATIENT SETUP ISSUES, THROUGH A SERIES OF AUDIBLE TONES, USER-INTERFACE MESSAGES AND INDICATOR LIGHTS, IF AND WHEN THEY EXPERIENCE ANY DIFFICULTIES WHILE USING THE DEVICE. WHEN THE M-SERIES DEVICE ACHIEVES A 'CHARGE READY' STATE AND NO ACCESSORIES ARE ATTACHED, AN AUDIBLE TONE IS ADMITTED AND THE SHOCK BUTTON ON THE FACE OF THE DEVICE WILL ILLUMINATE, INDICATING THAT THE BUTTON NEEDS TO BE DEPRESSED TO DISCHARGE THE STORED ENERGY. LIKEWISE, WHEN USING HANDS FREE MULTI-FUNCTION ELECTRODES OR OTHER ACCESSORIES THAT DO NOT HAVE A DISCHARGE SWITCH INCORPORATED IN THEM, THE SHOCK BUTTON WILL ILLUMINATE AS A "PRESS HERE" INDICATOR. IN THE EVENT THAT A DEFIBRILLATION ACCESSORY, EITHER EXTERNAL PADDLES OR INTERNAL HANDLES WITH A DISCHARGE SWITCH INCORPORATED, IS ATTACHED FOR USE, THE SHOCK BUTTON WILL REMAIN UNLIT WHEN THE 'CHARGE READY' TONE IS EMITTED FROM THE DEVICE. THIS IS AN INDICATION THAT THE DISCHARGE BUTTON(S) ON THE ACCESSORIES REQUIRES ACTUATION TO DISCHARGE THE STORED ENERGY. THE EXTERNAL PADDLES HAVE AN ADDED INDICATOR LIGHT ON THE APEX PADDLE WHICH WILL ILLUMINATE AT THE TIME A 'CHARGE READY' STATE IS ACHIEVED. REPORTS OF THIS TYPE ARE NOT TYPICALLY REPORTED, AS REMEDIAL ACTIONS WERE TAKEN BY THE ATTENDANTS TO PERFORM THE REQUIRED TASK. IN THIS PARTICULAR CASE, THE CLINICIANS CHECKED THE SYSTEM SETUP WHEN THE DEVICE DID NOT IMMEDIATELY DISCHARGE THE ENERGY AND OBSERVED THE DEVICE INDICATIONS AND THE DEVICE SHOCK BUTTON ON THE FACEPLATE WAS DEPRESSED TO DISCHARGE THE STORED DEFIBRILLATOR ENERGY, AND THERAPY WAS PROVIDED TO THE PT. UPON RECEIPT AND EVALUATION OF THE DEVICE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THAT INVESTIGATION.

    Description of Event or Problem · 1

    ZOLL DEFIBRILLATOR SET TO SHOCK PT AT 30 JOULES VIA INTERNAL PADDLES. WOULD NOT ADMINISTER SHOCK VIA PADDLES, HAD TO PRES "SHOCK" ON DEFIBRILLATOR BEFORE 30 JOULES WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL DEFIBRILLATOR LDD ZOLL MEDICAL CORP M SERIES *
    2 ZOLL INTERNAL PADDLES LDD ZOLL MEDICAL CORP M SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention