BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823596 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01337
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK BELT MESSAGES) WAS CONFIRMED. UPON RECEIPT THE MONITOR FAILED AN INCOMING TEST. THE CAUSE FOR THE ALARMS AND THE FAILURE WAS A PINCHED ORANGE (LEAD2-) WIRE IN ECG-C. THE ROOT CAUSE FOR THE PINCHED WIRE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A (B)(6) PATIENT WAS RECEIVING CONSTANT CHECK BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261044 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK