BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII(NO DRN)PKG/6 W/CAPACITOR

    MDR report key: 2132374 · Received June 13, 2011

    Report

    Report Number
    2648666-2011-00150
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. THEREFORE, THE ROOT CAUSE OF THE EVENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE DEVICE STOPPED WORKING. A BACK-UP DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII(NO DRN)PKG/6 W/CAPACITOR CAC STRYKER INSTRUMENTS PUERTO RICO 11067012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK