BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232962 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00269
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) HAS BEEN CONFIRMED. THE CAUSE OF THE MONITOR NOT POWERING UP HAS BEEN ISOLATED TO AN INTERMITTENT CONNECTION AT PIN 25 OF THE FLASH MEMORY. THE INTERMITTENT CONNECTION RESULTED IN THE FLASH MEMORY BECOMING CORRUPT. 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. NO ADVERSE EVENT RESULTED FORM THE CORRUPT MEMORY. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WAS "EMITTING A LOUD SCREECHING NOISE WHEN BATTERY WAS PLACED IN IT. [NOW] NEITHER BATTERY WILL POWER IT 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 CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR