BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODE MASTER XL

    MDR report key: 38826 · Received September 6, 1996

    Report

    Report Number
    3017388-1996-00035
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Date of Event
    August 7, 1996
    Report Date
    September 6, 1996
    Manufacturer
    HEWLETT-PACKARD COMPANY
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USER WAS PERFORMING A ROUTINE DAILY 100J TEST. USER ALLEGEDLY SUFFERED FROM ELECTRICAL SHOCK PERFORMING THE TEST WHILE THE PADDLES WERE IN THE POCKETS. NO VISUAL DAMAGE TO THE PADDLES. PADDLES ARE IN REVERSED POSITION (RIGHT PADDLE IN LEFT POCKET AND VICE VERSA). TOP COVER IS ONE OF THE MOUNTING STUDS. THE STUD WAS BROKEN AT THE LOCATION OF THE RIGHT HAND PADDLE POCKET. CALIBRATION IS GOOD. ROUTINE TEST IS GOOD. FIELD ENGINEER'S OPINION OF THE CAUSE: USER COULD HAVE TOUCHED THE METAL PARTS OF THE PADDLE ELECTRODES DURING TEST. 960827 FACTORY EVALUATION: ONLY THE EXTERNAL PADDLES WERE RETURNED FOR EVALUATION. INITIAL INSPECTION REVEALED NO DEFECTS. SUBSEQUENTLY HV TESTING SHOWED NO SIGN OF LEAKAGE AT 10 KV DC OR AT 6 KV AC. VOLTAGE WAS APPLIED BETWEEN EACH HV ELECTRODE AND FOIL FORMED AROUND ALL SURFACES OF THE HANDLES AREA OF THE PADDLES. ROOT CAUSE ANALYSIS: NO TROUBLE FOUND WITH THE PADDLE SET, INCLUDING HV INTEGRITY OF THE ISOLATION PROVIDED THE OPERATOR. 960827 FEEDBACK FORM FIELD ENGINEER ON BROKEN STUD: THIS APPEARS TO HAVE NOTHING TO DO WITH THE ALLEGED SHOCK EVENT. ORDERING A NEW TOP COVER TO BE INSTALLED BEFORE RETURNING THE UNIT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODE MASTER XL DEFIBRILLATOR LDD HEWLETT-PACKARD COMPANY M1723B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other