BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881176 · Received November 15, 2012

    Report

    Report Number
    3008642652-2012-03035
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    September 15, 2012
    Report Date
    November 15, 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 (PATIENT TREATED) WAS UNABLE TO BE CONFIRMED. UPON INVESTIGATION, THERE WAS EXTENSIVE ELECTRICAL DAMAGE THE VARIOUS COMPONENTS OF THE COMPUTER/ANALOG (C/A) BOARD SN (B)(4) AND DEFIBRILLATOR BOARD SN (B)(4), INCLUDING DAMAGE TO THE +5V, -5V, 5.4V, 3.3V AND 1.8V POWER SUPPLIES ON THE C/A BOARD. THE DAMAGED PCA'S PREVENTED THE RECOVERY OF THE PATIENT FLAG FILES. LIMITED ECG DATA WAS AVAILABLE IN THE HOLTER DOWNLOAD FROM THE DAY OF THE ALLEGED EVENT. THE 30 MINUTE RECORDING SHOWS A NON-TREATABLE RHYTHM AND NO INDICATION THAT A TREATMENT WAS DELIVERED. UPON ENGINEERING INVESTIGATION, IT WAS DETERMINED THAT THE PCA DAMAGE WAS LIKELY CAUSED BY A FAILURE OF A CHARGE RELAY OR CONTROL CIRCUITRY DURING AN INTERNAL DIAGNOSTIC TEST. BASED ON THE DAMAGE OBSERVED ON THE C/A AND DEFIBRILLATOR BOARDS IT CAN BE CONFIRMED THAT NO PULSE WAS DELIVERED TO THE PATIENT. THE ROOT CAUSE OF THE DAMAGE TO THE CHARGE RELAY OR CONTROL CIRCUITRY CANNOT BE POSITIVELY IDENTIFIED. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT TREATED) WAS UNABLE TO BE CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED THE CURRENT AND FALL-OFF TESTS. UPON EVALUATION (B)(4), A 6-LINE ESD PROTECTION DIODE ARRAY WAS SHORTED ON THE DISTRIBUTION NODE (DN) PCA SN (B)(4), SHORTING THE +5V POWER SUPPLY TO GROUND. UPON ENGINEERING INVESTIGATION, IT WAS DETERMINED THAT THE CAUSE OF THE SHORTED COMPONENT WAS LIKELY DAMAGE TO THE +5V OR 3.3V POWER SUPPLIES ON THE MONITOR C/A. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BOARDS. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR AND ELECTRODE BELT. DEVICE MANUFACTURE DATE: SN (B)(4): 03/2011, SN (B)(4): 09/2010.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE RECEIVED A TREATMENT. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR AND ELECTRODE BELT.

    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 52 YR