BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173258 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01515
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 12, 2013
    Report Date
    June 5, 2013
    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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) WAS CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. UPON EVAL, THE MONITOR PRODUCED A SEGMENTATION FAULT DURING THE FLASH TEST. DESTRUCTIVE TESTING REVEALED A FRACTURE BETWEEN THE INTER-METALLIC LAYER AND THE COPPER PAD OF THE FLASH BGA COMPONENT, U102, ON COMPUTER ANALOG (CA) BOARD SN (B)(4), THE FRACTURE BETWEEN THE INTERMETALLIC LAYER AND THE COPPER PAD OF THE BGA OCCURRED AT PIN A25 ON THE C/A BOARD. THE FRACTURE BETWEEN THE COPPER PAD AND INTER-METALLIC LAYER OF THE BGA COMPONENT LIKELY CAUSED THE INABILITY TO POWER ON. A ROOT CAUSE INVESTIGATION FOR THE FRACTURE IS CURRENTLY UNDERWAY. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) PT'S SPOUSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WAS NOT POWERING ON. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253546 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR