BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3964052 · Received May 22, 2014

    Report

    Report Number
    3008642652-2014-01568
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON RECEIPT THE ELECTRODE BELT FAILED THE PULSE LEAD HI-POT TEST AND THE THERAPY ELECTRODE RECOGNITION TEST. UPON INVESTIGATION THERE WAS AN OPEN PULSE WIRE IN THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE. THE ROOT CAUSE OF THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM DEFECTIVE ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT. DEVICE EVALUATION OF BATTERY PACKS SN (B)(4) AND SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY PACKS WILL NOT HOLD CHARGE) IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION. NO ADVERSE EVENT RESULTED FROM THE ALLEGEDLY DEFICIENT BATTERY PACKS. THE PATIENT RECEIVED TWO REPLACEMENT BATTERY PACKS. DEVICE MANUFACTURER DATES: SN: (B)(4) 05/01/2012; SN (B)(4) 11/01/2012.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT ADJUST BELT/CHECK BELT MESSAGES. IN ADDITION, THE PATIENT'S NURSE REPORTED THAT THE BATTERIES WOULD NOT HOLD CHARGE AND THAT ONE WOULD NOT POWER UP THE MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT AND TWO REPLACEMENT BATTERY PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306850 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR