BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3072326 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00872
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY - DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) IS CURRENTLY UNDERWAY. AS RECEIVED, THE BATTERY CHARGER WOULD NOT POWER ON. UPON SERVICE INVESTIGATION, THERE WAS AN MD5 FAILURE DURING REPROGRAMMING OF THE CHARGER, WHICH IS A FLASH MEMORY FAILURE. THE CAUSE OF THE CHARGER NOT POWERING ON WAS ISOLATED TO FLASH MEMORY COMPONENTS U102 AND U105 ON THE COMPUTER / ANALOG BOARD. 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 WAS SUBMITTED FOR FDA REVIEW ON (B)(4) 2013 AND IS CURRENTLY UNDER REVIEW. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE LAST PT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, BATTERY CHARGER/MODEM SN (B)(4) WOULD NOT POWER UP. THE LAST PT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142030 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA