BEUDAMED
    FDA Adverse Event Death Summary report: N

    CMP DEFIBRILLATION ECG ELECTRODE

    MDR report key: 3503372 · Received December 3, 2013

    Report

    Report Number
    2246340-2013-00001
    Event Type
    Death
    Date Received
    December 3, 2013
    Date of Event
    October 25, 2013
    Report Date
    November 27, 2013
    Manufacturer
    CARDIO MEDICAL PRODUCTS, INC.
    Product Code
    LDD
    PMA / PMN Number
    K103159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO OUR MANUFACTURING FACILITY FOR EVALUATION AND IT WAS DETERMINED THAT THE PRODUCT WAS WORKING WITHIN THE DESIGNED PARAMETERS.

    Description of Event or Problem · 1

    A FEMALE HAD CARDIAC ARREST. SHE WAS BROUGHT INTO THE HOSPITAL ER DEPARTMENT, EXTERNAL DISPOSABLE DEFIBRILLATOR PADS WERE APPLIED TO THE PATIENT. THE PATIENT WAS DEFIBRILLATED SIX (6) TIMES. UPON THE SECOND SHOCK, THE DISPOSABLE PADS HAD A SPARK/ARC. THE PATIENT WAS ELDERLY AND EXPIRED. THE EXTERNAL DISPOSABLE DEFIBRILLATOR PADS HAD BEEN OPENED IMPROPERLY (NOT FOLLOWING INSTRUCTIONS) AND PLACED ON PATIENT. THE DEPARTMENT NOTICED THE FOAM COVER ON PATIENT SIDE OF PADS HAD BEEN REMOVED EXPOSING A METAL RIVET/ CONDUCTIVITY WIRE, RESULTING IN THE SPARK/ARC THAT WAS OBSERVED DURING TREATMENT. WE, THE OEM, WERE NOTIFIED TEN (10) DAYS POST EVENT. WE IMMEDIATELY REQUESTED PRODUCT FROM EVENT, ALONG WITH ANY EXISTING INVENTORY. THE PRODUCT SAMPLES WERE RETURNED TO OUR FACILITY WHERE A COMPLETE ANALYSIS AND TESTING WAS PERFORMED TO DETERMINE POSSIBLE REASON FOR METAL EXPOSURE. HOSPITAL BIO-ENGINEER ALERTED US THAT THE PROTECTIVE FOAM PADDING COVERING THE METAL RIVET BEEN IMPROPERLY REMOVED PRIOR TO APPLICATION TO PATIENT WHICH WOULD HAVE CAUSED THE SPARK DESCRIBED IN THE EVENT CLAIM. THE HEALTHCARE PROVIDER DID NOT PROPERLY REMOVE BACKING FROM THE DISPOSABLE DEFIBRILLATOR PAD THUS CHANGING THE INTEGRITY. THE PRODUCT PACKAGING HAS EASILY IDENTIFIABLE INSTRUCTIONS, AS WELL AS PICTORIAL DIAGRAMS OF PROPER REMOVAL OF BACKING PRIOR TO APPLICATION OF DISPOSABLE EXTERNAL DEFIBRILLATOR ELECTRODE PAD TO PATIENT. BASED ON THE EXPLANATION PROVIDED BY (B)(6), THE BIOMEDICAL ENGINEER AT THE HOSPITAL, AND PROVIDED IN DETAIL TO THE OEM, THE HEALTHCARE PROVIDER IMPROPERLY REMOVED THE BACKING OFF THE DISPOSABLE ELECTRODE, THEREFORE EXPOSING THE METAL RIVET/ WIRE. THE HEALTHCARE PROVIDER APPLIED THE PRODUCT TO PATIENT WITHOUT EXAMINING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625367 CMP DEFIBRILLATION ECG ELECTRODE EXTERNAL DEFIB PADS LDD CARDIO MEDICAL PRODUCTS, INC. LOH401-S Y032213-02

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death