BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2940513 · Received December 20, 2012

    Report

    Report Number
    3008642652-2012-03357
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 17, 2012
    Report Date
    December 20, 2012
    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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON, OVERHEATING) HAS BEEN CONFIRMED. UPON EVAL, THERE WAS EXTENSIVE DAMAGE TO SEVERAL COMPONENTS ON THE C/A (COMPUTER/ANALOG) BOARD AND DEFIBRILLATOR BOARD. MULTIPLE POWER SUPPLIES WERE SHORTED (5V, -5V, 5.4V, 1.8V, 3.3V ON THE C/A BOARD), (1.8V, 3.3V IN PLD). COMPONENTS U1003, R45, R689, R684 AND U1005 WERE ALL DAMAGED ON COMPUTER/ANALOG (C/A) BOARD SN (B)(4). ON THE DEFIBRILLATOR BOARD, D11 WAS SHORTED AND U15, U17, U18 WERE THERMALLY DAMAGED. THE CAUSE OF THE INABILITY TO POWER ON WAS THE DAMAGE TO THE C/A AND DEFIBRILLATOR BOARDS. THE CAUSE FOR THE DAMAGE IS HIGH CURRENT. THE CAUSE FOR THE HIGH CURRENT IS BROKEN LEADS ON HIGH-VOLTAGE CAPACITOR C21 IN THE DEFIBRILLATOR BOARD SN (B)(4). THE ROOT CAUSE FOR THE BROKEN LEADS ON C21 COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR IMPACTING A HARD SURFACE. 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 PCA STRAIN WAS SUBMITTED FOR FDA REVIEW ON (B)(4) 2012 AND IS CURRENTLY UNDER REVIEW. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WAS OVERHEATING AND THE SCREEN WAS BLACK. 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 59 YR