BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173139 · Received May 31, 2013

    Report

    Report Number
    3008642652-2013-01451
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 29, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO POWER UP. DESTRUCTIVE TESTING REVEALED A SEPARATION OF THE COPPER PAD AND THE LAMINATE AT PIN H8 OF FLASH BGA COMPONENT U102 ON C/A BOARD SN (B)(4). THE SEPARATION OF THE PAD AND LAMINATE CAUSED THE POWER-UP FAILURE. THE ROOT CAUSE FOR THE SEPARATION OF THE PAD AND LAMINATE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR MAD A SQUEALING NOISE AND THEN WOULD NOT POWER UP. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241483 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR