BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173288 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01519
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 5, 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 CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. UPON EVAL THE BATTERY CHARGER/MODEM WAS UNABLE TO POWER UP. THE CAUSE FOR THE POWER-UP FAILURE WAS ISOLATED TO EXTENSIVE CONTAMINATION WITHIN THE CHARGER. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNK FOREIGN MATERIAL. THE REPORTED PROBLEM (DAMAGED CABLE OR WIRES EXPOSED) HAS NOT BEEN ABLE TO BE CONFIRMED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGE/MODEM. THE LAST PT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING EVAL, BATTERY CHARGER/MODEM SN (B)(4) WAS UNABLE TO POWER UP. THE LAST PT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254121 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA