BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3190999 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01667
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY CHARGER WOULD NOT POWER ON. UPON SVC INVESTIGATION, THERE WAS AN MD5 FAILURE DURING REPROGRAMING OF THE CHARGER, WHICH IS A FLASH MEMORY FAILURE. ADDITIONALLY, THE BATTERY BOARD WAS CONTAMINATED DUE TO INGRESS OF AN UNK LIQUID. THE CAUSE OF THE CHARGER NOT POWERING ON WAS ISOLATED TO FLASH MEMORY COMPONENTS U102 AND U105 ON THE COMPUTER ANALOG BOARD SN (B)(4). THE FLASH MEMORY 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 DEFECTIVE COMPONENTS. THE PT REC'D A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER/MODEM WOULD NOT POWER UP. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283629 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR