BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3924737 · Received June 30, 2014

    Report

    Report Number
    3008642652-2014-01979
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAVE NOT YET BEEN RETURNED TO ZOLL FOR EVALUATION. THERE IS NO EVIDENCE AVAILABLE AT THIS TIME TO SUGGEST THE DEVICE WAS UNABLE TO DETECT AND TREAT WHILE IN USE. A SUPPLEMENTAL REPORT WILL BE SENT IF A DEFICIENCY IS IDENTIFIED UPON EVALUATION. THE LIFEVEST (LV) DETECTED ATRIAL FIBRILLATION (AV) WITH RAPID VENTRICULAR RESPONSE AT 180 BPM AND DELIVERED FOUR TREATMENTS ON (B)(6) 2014, AT 8:00:35, 8:00:59, 10:27:23, AND 10:54:18. THE POST SHOCK RHYTHMS WERE AF WITH RAPID VENTRICULAR RESPONSE AT 172 BPM, AF WITH RAPID VENTRICULAR RESPONSE AT 128 BPM, AF AT 99 BPM, AND AF AT 96 BPM RESPECTIVELY. A PSR DELIVERED A NEW MONITOR AND NEW ELECTRODE BELT TO THE PATIENT AT 11:42:45. REVIEW OF THE PATIENT'S FLAGS AND ECG STRIPS DOES NOT INDICATE THAT THE DEVICE MALFUNCTIONED. ABOUT 7 HOURS LATER, AT 18:47:26, THE LV DETECTED VENTRICULAR TACHYCARDIA AND DELIVERED A TREATMENT, WITH A POST SHOCK RHYTHM OF AF AT 75 BPM. AFTER THE TREATMENT, THE PATIENT'S WIFE DISCONNECTED THE ELECTRODE BELT AND REMOVED THE BATTERY FROM THE MONITOR. A NURSE REPORTED THE PATIENT PASSED AWAY 7 HOURS LATER AT 2:20:00 ON (B)(6) 2014, IN THE HOSPITAL. ALTHOUGH THE PATIENT WAS WEARING THE LV AT TIME OF DEATH, THE ELECTRODE BELT WAS DISCONNECTED AND THE BATTERY HAD BEEN REMOVED FROM THE MONITOR. REVIEW OF THE PATIENT'S FLAGS AND ECG STRIPS DOES NOT INDICATE THAT THE DEVICE MALFUNCTIONED. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE. ADDITIONAL DEVICE MFR DATE: 06/01/2011.

    Description of Event or Problem · 1

    ON (B)(6) 2014, ZOLL CUSTOMER SUPPORT WAS NOTIFIED BY A NURSE THAT A (B)(6) YEAR OLD MALE PATIENT HAD RECEIVED A TREATMENT. AFTER THE TREATMENT, THE PATIENT'S WIFE DISCONNECTED THE PATIENT'S ELECTRODE BELT AND REMOVED THE BATTERY FROM THE PATIENT'S MONITOR. THE PATIENT PASSED AWAY HOURS LATER WHILE IN THE HOSPITAL STILL WEARING THE DEVICE WITH THE ELECTRODE BELT DISCONNECTED AND THE BATTERY REMOVED. NO DEFICIENCIES WERE ALLEGED AGAINST THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378672 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death