BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2140334 · Received June 15, 2011

    Report

    Report Number
    3008642652-2011-00045
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    January 28, 2011
    Report Date
    June 13, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACKS (B)(4) ARE COMPLETED. THE REPORTED PROBLEM (PHYSICAL DAMAGE) HAS BEEN CONFIRMED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK. RETURNED TO MANUFACTURER: BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011. DEVICE MANUFACTURE DATE: BATTERY PACK (B)(4): 03/2010; BATTERY PACK (B)(4): 05/2008; BATTERY PACK (B)(4): 12/2008; BATTERY PACK (B)(4): 01/2009; BATTERY PACK (B)(4): 06/2009; BATTERY PACK (B)(4): 10/2009. DATE RECEIVED BY MANUFACTURER: BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011; BATTERY PACK (B)(4): (B)(4) 2011. BATTERY PACK (B)(4) WAS FOUND TO HAVE A BENT PIN IN THE CONNECTOR. PIN 4 WAS BENT AND PREVENTED THE BATTERY FROM SUCCESSFULLY COMMUNICATING WITH THE CHARGER/MONITOR. THE ROOT CAUSE OF THE BENT PIN CANNOT BE POSITIVELY IDENTIFIED BUT MAY HAVE RESULTED FROM BUMPING OR DROPPING THE PACK ON A HARD SURFACE. AS RECEIVED, THE CONNECTOR SHELL OF BATTERY PACK (B)(4) WAS DAMAGED BY PIN 1 AND PIN 2. THE DAMAGED CONNECTOR SHELL PREVENTED THE BATTERY PACK FROM FITTING INTO THE MONITOR. THE ROOT CAUSE OF THE DAMAGED CONNECTOR SHELL CANNOT BE POSITIVELY IDENTIFIED, BUT MAY HAVE RESULTED FROM BUMPING OR DROPPING THE PACK ON A HARD SURFACE. BATTERY PACK (B)(4) WAS FOUND TO HAVE A BENT PIN IN THE CONNECTOR. PIN 6 WAS BENT AND PREVENTED THE BATTERY FROM SUCCESSFULLY COMMUNICATING WITH THE CHARGER/MONITOR. THE ROOT CAUSE OF THE BENT PIN CANNOT BE POSITIVELY IDENTIFIED BUT MAY HAVE RESULTED FROM BUMPING OR DROPPING THE PACK ON A HARD SURFACE. AS RECEIVED, THE CONNECTOR OF BATTERY (B)(4) WAS DAMAGED, NOT ALLOWING THE BATTERY TO COMMUNICATE. THE ROOT CAUSE OF THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT MAY HAVE RESULTED FROM BUMPING OR DROPPING THE PACK ON A HARD SURFACE. BATTERY PACK (B)(4) WAS FOUND TO HAVE A BENT PIN IN THE CONNECTOR. PIN 4 WAS BENT AND PREVENTED THE BATTERY FROM SUCCESSFULLY COMMUNICATING WITH THE CHARGER/MONITOR. THE ROOT CAUSE OF THE BENT PIN CANNOT BE POSITIVELY IDENTIFIED BUT MAY HAVE RESULTED FROM BUMPING OR DROPPING THE PACK ON A HARD SURFACE. BATTERY PACK (B)(4) WAS FOUND TO HAVE A BROKEN WHITE WIRE WITHIN THE BATTERY PACK WHERE THE WIRE ATTACHES TO THE BATTERY CELLS. THE ROOT CAUSE OF THE BROKEN WIRE HAS NOT BEEN DETERMINED BUT MAY HAVE BEEN CAUSED BY A SEVERE SHOCK FROM DROPPING THE PACK.

    Description of Event or Problem · 1

    A (B)(6) RETURNED BATTERY PACKS (B)(4), (B)(4), (B)(4), (B)(4), (B)(4) AND (B)(4) INDICATING THERE WAS PHYSICAL DAMAGE TO THE BATTERY PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK