BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2231354 · Received July 26, 2011

    Report

    Report Number
    3008642652-2011-00293
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    March 28, 2011
    Report Date
    July 26, 2011
    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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BENT PINS OR DAMAGED E-BELT CONNECTOR) HAS BEEN CONFIRMED. UPON EVAL, THE TRUNK CABLE CONNECTOR WAS DAMAGED. THE CAUSE FOR THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY DETERMINED, BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE WHEN THE PT DROPPED HIS UNIT. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT, WAS CONTACTED BY ZOLL CUSTOMER SUPPORT TO DISCUSS AN UNRELATED COMPLAINT. DURING THE TELEPHONE CONVERSATION, THE PT ADMITTED DROPPING HIS MONITOR AND STRAINING THE ELECTRODE BELT CABLE DURING THE EVENT. HE STATED THAT THE DEVICE SEEMS TO BE OPERATING NORMALLY; HOWEVER, ZOLL CUSTOMER SUPPORT ISSUED A REPLACEMENT 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 53 YR