BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1804834 · Received August 4, 2010

    Report

    Report Number
    3002158293-2010-00807
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    June 20, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED TO MANUFACTURER ON: MONITOR SN (B)(4): 07/20/2010, BATTERY PACK SN (B)(4): 07/20/2010, BATTERY PACK SN (B)(4): 7/23/2010. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 02/2009, BATTERY PARK SN (B)(4): 01/2008, BATTERY PACK SN (B)(4): 01/2008. DATE RECEIVED BY MANUFACTURER: MONITOR SN (B)(4): 07/20/2010, BATTERY PACK SN (B)(4): 07/20/2010, BATTERY PACK SN (B)(4): 7/23/2010. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR WILL NOT POWER ON WITH EITHER BATTERY) WAS CONFIRMED. THE MONITOR'S BATTERY CONNECTOR PINS WERE BENT, PREVENTING THE BATTERIES FROM BEING PLUGGED INTO THE MONITOR. THE CAUSE FOR THE BENT BATTERY PINS WAS NOT POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO A MISALIGNMENT PROBLEM WHEN THE PATIENT INSERTED THE ISSUED BATTERY PACK INTO THE MONITOR. THE ROOT CAUSE FOR THE MISALIGNMENT PROBLEM WAS NOT POSITIVELY IDENTIFIED. A ROOT CAUSE ANALYSIS FOR BATTERY PACKS SN (B)(4) AND SN (B)(4) IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE NURSE ASSISTING A (B)(6) MALE PATIENT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT SERVICE TO REPORT THAT NEITHER OF THE PATIENT'S BATTERIES WOULD POWER ON THE MONITOR. THE PATIENT WAS PROVIDED WITH A REPLACEMENT MONITOR AND TWO REPLACEMENT BATTERY PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR