BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080845 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00983
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE BELT FAILED THE HI-POT AND +P INSULATION RESISTANCE TESTS. UPON INVESTIGATION, THE CABLE CONNECTING ECG C AND D TO THE DISTRIBUTION NODE (DN) WAS PULLED FROM THE STRAIN RELIEF AT THE DN AND TRUNK CABLE CONNECTOR WAS CRACKED. THE CAUSE OF THE TEST FAILURES WAS ISOLATED TO THE PULLED CABLE AND DAMAGED CONNECTOR. THE ROOT CAUSE OF THE DAMAGED CABLE AND CONNECTOR WAS UNABLE TO BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, BELT SN (B)(4) FAILED THE HI-POT AND +P INSULATION RESISTANCE TESTS. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158000 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA