BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232987 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00252
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INITIAL INVESTIGATION, THE REPORTED PROBLEM (PULSE CURRENT FAULTS) WAS UNABLE TO BE DUPLICATED. AN ENGINEERING ANALYSIS ON THE THIS MONITOR FOUND THAT THE CAUSE OF THE PULSE CURRENT FAULTS WAS DUE TO A DEFECTIVE RESISTOR )COMPONENT R84) ON THE C/A BOARD. THE RESISTOR WAS CRACKED AT THE WELD JOINT, CAUSING THE MONITOR TO DETECT CURRENT IN THE LINE WHEN NO PULSE DELIVERY WAS NECESSARY. THIS COULD AFFECT THE SIGNAL SENSING CIRCUITRY. THE ROOT CAUSE OF THE DEFECTIVE RESISTOR COULD NOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE BROKEN RESISTOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT REVIEWED THE DOWNLOAD OF AN (B)(6) MALE PT WHICH REVEALED EXCESSIVE PULSE CURRENT FAULTS. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR