BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3223921 · Received July 5, 2013

    Report

    Report Number
    3008642652-2013-01758
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 1, 2013
    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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON SERVICE EVAL, THE SOLDER CONNECTIONS FOR THE RED AND WHITE PP+ WIRES IN THE DISTRIBUTION NODE (DN) WERE BROKEN. THIS CREATED AN OPEN CONNECTION IN THE DN. THE CAUSE OF THE FAILED DETECT AND TREAT TEST WAS THE OPEN CONNECTION BETWEEN THE WIRES AND THE DN PCA. THE ROOT CAUSE OF THE BROKEN CONNECTION CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE IMPROPER SOLDER CONNECTION. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, BELT SN (B)(4) FAILED THE DETECT AND TREAT TEST. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307111 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA