BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2011969 · Received February 14, 2011

    Report

    Report Number
    3002158293-2011-00169
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 10, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BENT MONITOR PINS) HAS BEEN CONFIRMED. THE MONITOR'S BATTERY CONNECTOR PINS WERE BENT, PREVENTING THE BATTERIES FROM BEING INSERTED INTO THE MONITOR. THE CAUSE FOR THE BENT BATTERY PINS WAS NOT POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO MISALIGNMENT OF A BATTERY WHEN INSERTED INTO THE MONITOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6), FEMALE, PATIENT, CONTACTED ZOLL CUSTOMER SUPPORT SERVICE TO REPORT THAT SHE COULD NOT INSERT A BATTERY INTO HER MONITOR. THE PATIENT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR