BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2938256 · Received December 21, 2012

    Report

    Report Number
    3008642652-2012-03244
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY - DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE MONITOR WAS NOT POWERING ON AND WAS DRAWING EXCESSIVE CURRENT (3 AMPS). UPON EVALUATION COMPONENT C9 WAS SHORTED. THE C9 COMPONENT IS A EQUIVALENT SERIES RESISTANCE CAPACITOR LOCATED ON THE BIPHASIC DEFIBRILLATOR PCA BOARD OF THE MONITOR. THE CAUSE FOR THE INABILITY TO POWER UP WAS THE SHORTED COMPONENT. THE ROOT CAUSE FOR THE SHORTED C9 COMPONENT COULD NOT BE POSITIVELY DETERMINED. DEVICE EVALUATION OF BATTERY PACK SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (WILL NOT POWER ON MONITOR) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY WOULD NOT CHARGE IN A CHARGER, OR POWER ON A MONITOR. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. DEVICE MFR DATE: MONITOR: 09/2012, BATTERIES: 07/2012, SN (B)(4): 08/2011, SN (B)(4): 09/2011, SN (B)(4): 09/2011, SN (B)(4): 03/2012, SN (B)(4): 03/2012, SN (B)(4): 03/2012.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S DAUGHTER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WOULD NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR AND TWO BATTERY PACKS. DEVICE EVALUATION OF BATTERY PACKS SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (WILL NOT POWER ON MONITOR) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY WOULD CHARGE IN A CHARGER, BUT WOULD NOT POWER ON A MONITOR. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION. NO ADVERSE EVENT RESULTED FROM THE SHORTED MONITOR COMPONENT OR THE DEFECTIVE BATTERIES. THE PATIENT RECEIVED A REPLACEMENT MONITOR AND TWO BATTERY PACKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR