BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2961468 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00193
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 16, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON¿T CONNECT TO MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE CONNECTOR PINS WERE BENT IN A SWIRL PATTERN, WHICH PREVENTED THE ELECTRODE BELT FROM CONNECTING TO A MONITOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR PINS COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE WHEN CONNECTING THE ELECTRODE BELT TO THE PATIENT¿S MONITOR. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR PINS. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER ELECTRODE BELT WOULD NOT CONNECT TO HER MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28299 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR