BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173256 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01487
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY/CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) WAS CONFIRMED. AS RECEIVED, THE BATTERY CHARGER WAS CONSTANTLY RESETTING. THE CAUSE OF THE RESETS WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON C/A BOARD (B)(4). THE FLASH MEMORY LIKELY HAD AN INTERMITTENT BGA 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. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE TO REDUCE THE PCA STRAIN ((B)(4)) WAS APPROVED BY FDA ON (B)(4) 2013. IMPLEMENTATION BEGAN ON (B)(4) 2013. NO ADVERSE EVENT RESULTED FROM THE DAMAGED COMPONENTS. THE PATIENT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERY CHARGER/MODEM WAS NOT PROPERLY CHARGING THE PATIENT'S BATTERY PACKS. THE PATIENT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253634 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR