BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12860554 · Received November 23, 2021

    Report

    Report Number
    3008642652-2021-10372
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005029
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF BATTERY HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY WAS UNABLE TO POWER ON A MONITOR OR CHARGE. UPON EVALUATION, THE BATTERY PACK TRI-CELLS WERE MIS-MATCHED. THE ROOT CAUSE OF THE MIS-MATCHED CELLS WAS UNABLE TO BE POSITIVELY IDENTIFIED. THERE WAS NO DEATH OR ADVERSE EVENT ASSOCIATED WITH THE BATTERY MALFUNCTION. DEVICE EVALUATION OF BATTERY CHARGER SN  (B)(6) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) WAS CONFIRMED. UPON INVESTIGATION THE CHARGER WAS RESETTING AND UNABLE TO CHARGE A BATTERY PACK.  THE CHARGER EXHIBITED A FAILURE AT PLD COMPONENT U1003 AND PXA COMPONENT U104 ON THE C/A BOARD. THE ROOT CAUSE FOR THE U1003 AND U104 FAILURE COULD NOT BE POSITIVELY IDENTIFIED. THERE WAS NO DEATH OR ADVERSE EVENT ASSOCIATED WITH THE CHARGER MALFUNCTION.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) WAS CONFIRMED. UPON INVESTIGATION THE CHARGER WAS RESETTING AND UNABLE TO CHARGE A BATTERY PACK. THE CHARGER EXHIBITED A FAILURE AT PLD COMPONENT U1003 AND PXA COMPONENT U104 ON THE C/A BOARD. THE ROOT CAUSE FOR THE U1003 AND U104 FAILURE COULD NOT BE POSITIVELY IDENTIFIED. THERE WAS NO DEATH OR ADVERSE EVENT ASSOCIATED WITH THE CHARGER MALFUNCTION.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A PATIENT'S BATTERY HAD FAULTS AND WAS UNABLE TO POWER ON A MONITOR. A US DISTRIBUTOR REPORTED THAT A PATIENT'S BATTERY CHARGER WAS RESETTING.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A PATIENT'S BATTERY CHARGER WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760186 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown