BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3061493 · Received March 27, 2013

    Report

    Report Number
    3008642652-2013-00746
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 14, 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 BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE PACK HAD A DAMAGED BATTERY CONNECTOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE LAST PT TO USE THIS BATTERY PACK DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SVC DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, THE CONNECTOR ON BATTERY PACK SN (B)(4) WAS DAMAGED. THE LAST PT TO USE THIS BATTERY DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127132 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA