BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3090063 · Received April 19, 2013

    Report

    Report Number
    3008642652-2013-01069
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 17, 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 EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT, THE ELECTRODE BELT FAILED THE HI-POT AND FALL-OFF TESTS. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO THE FRONT THERAPY ELECTRODE (TE) AND THE CABLE CONNECTING THE DN TO ECG "C" AND "D" WERE PULLED FROM THEIR STRAIN RELIEFS AT THE DN. THE PULLED DN TO FRONT TE CABLE DAMAGED CONNECTOR J703, WHICH CONNECTS THIS CABLE TO THE DN PRINTED CIRCUIT ASSEMBLY. THE CAUSE OF THE TEST FAILURES WAS THE DAMAGED CABLES, INTERNAL WIRES AND CONNECTOR. THE ROOT CAUSE FOR THE DAMAGED CABLES, WIRES AND CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY PHYSICAL ABUSE, IN THE FORM OF EXCESSIVE FORCE ON THE CABLES. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THERE IS NO EVIDENCE TO SUGGEST THAT THE ELECTRODE BELT WAS DEFECTIVE DURING PT USE.

    Description of Event or Problem · 1

    (B)(6) MALE PT'S ELECTRODE BELT WAS RETURNED TO ZOLL FOR AN UNRELATED ISSUE. UPON SERVICE INVESTIGATION, THE ELECTRODE BELT HAD MULTIPLE DAMAGED CABLES AND FAILED THE HI-POT AND FALL-OFF TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169459 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR