BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2890886 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03094
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    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 BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (EQUIPMENT PROBLEM DURING PATIENT SET-UP) WAS CONFIRMED. UPON INVESTIGATION CONTAMINATION WAS DISCOVERED ON THE CHARGER/MODEM'S BATTERY BOARD. THE ROOT CAUSE FOR THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNKNOWN LIQUID. IN ADDITION THE CHARGER WAS EXPERIENCING RESETS. THE CAUSE OF THE PROBLEM WAS ISOLATED TO FLASH MEMORY COMPONENTS U102 AND U105 ON COMPUTER ANALOG (CA) BOARD SN (B)(4). THE FLASH MEMORY HAD AN INTERMITTENT CONNECTION. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED SOLDER CONNECTION INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE FRACTURED CONNECTION MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A BATTERY CHARGER/MODEM PROBLEM DURING THE SET-UP FOR A (B)(6) FEMALE PATIENT. THE PSR WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR