BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2920565 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03194
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 2, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO POWER UP. THE CAUSE OF THE PROBLEM WAS ISOLATED TO A FRACTURED BGA SOLDER CONNECTION ON RAM CHIPS U100 AND U101. THE ROOT CAUSE OF THE FRACTURED BGA SOLDER CONNECTION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE STRESS ON THE MONITOR C/A BOARD. 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) 2012 AND IS CURRENTLY UNDER REVIEW. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER UP. THE PT WAS ISSUED 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 CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR