BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WD 4000 SYSTEM

    MDR report key: 3221473 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01767
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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 (MONITOR MADE A LOUD SQUEAL AND SCREEN WENT BLANK) WAS CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. UPON SERVICE INVESTIGATION, THERE WAS AN MDR FAILURE DURING REPROGRAMMING OF THE MONITOR, WHICH IS A FLASH MEMORY FAILURE. THE CAUSE OF THE MD5 FAILURE WAS ISOLATED TO FLASH MEMORY COMPONENTS U102 AND U105 ON COMPUTER / ANALOG BOARD SN (B)(4). THE FLASH MEMORY COMPONENTS HAD AN INTERMITTENT 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 ((B)(4)) TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON (B)(4) 2012. IMPLEMENTATION BEGAN ON (B)(4) 2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE MONITOR. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE DAUGHTER OF A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR MADE A LOUD SQUEALING NOISE AND THEN THE SCREEN WENT BLANK. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300672 LIFEVEST WD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR