BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2063026 · Received March 16, 2011

    Report

    Report Number
    3002158293-2011-00308
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 14, 2011
    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 (VELCRO CAME OFF) WAS NOT INVESTIGATED UPON RECEIPT. HOWEVER, SERVICING OF THE ELECTRODE BELT DETECTED A REPORTABLE EVENT. THE ELECTRODE BELT HAD BENT CONNECTOR PINS AND THE TRUNK CABLE WAS PINCHED. THE CAUSE FOR THE BENT CONNECTOR PINS AND PINCHED TRUNK CABLE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR AND DAMAGED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE BOYFRIEND OF A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S ELECTRODE BELT WAS MISSING VELCRO. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT. SERVICING OF THE ELECTRODE BELT DETECTED A REPORTABLE EVENT. THE PT'S ELECTRODE BELT CONNECTOR AND CABLE WAS DAMAGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR