BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2904557 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03172
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE CAUSE OF THE BATTERY FAULT IS CONTAMINATION ON THE PCA BOARD. THE CAUSE OF THE CONTAMINATION IS LIQUID INGRESS. THE ROOT SOURCE OF THE LIQUID INGRESS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE LAST PATIENT TO USE THIS BATTERY PACK DID NOT REPORT ANY ISSUES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, THERE WAS A BATTERY FAULT. THE LAST PATIENT TO USE THIS BATTERY PACK DID NOT REPORT ANY DEFICIENCIES.

    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 NA