BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2961416 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00170
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 15, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE WHITE WIRE CONNECTING THE PCA TO THE BATTERY CELLS WAS BROKEN AT THE CELLS. THIS RESULTED IN AN INABILITY TO CHARGE TO FULL CAPACITY. THE ROOT CAUSE FOR THE BROKEN WHITE WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY SEVERE SHOCK FROM PHYSICAL IMPACT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE LAST PATIENT TO USE THIS BATTERY PACK DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, BATTERY PACK SN (B)(4) WAS FOUND TO HAVE A BROKEN WHITE WIRE. THE LAST PATIENT TO USE THIS BATTERY PACK DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28308 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA