BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2704395 · Received August 17, 2012

    Report

    Report Number
    2090040-2012-00022
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    July 17, 2012
    Report Date
    July 23, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLI
    PMA / PMN Number
    K033436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER CATHETER WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR AN EVALUATION. INFORMATION SUCH AS SERIAL NUMBER, LOT NUMBER, MANUFACTURE DATE, AND EXPIRATION DATE ARE ALL UNKNOWN. ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THEY WERE TRYING TO USE A GE CONSOLE. THESE ULTRASOUND CATHETERS WERE SIEMENS CATHETERS. THE IDENTIFICATION PINS ON THE GE CONSOLES ARE DIFFERENT THAN THE IDENTIFICATION PINS ON THE SIEMENS CONSOLES, WHICH IS REFLECTED BY THE FLEX CIRCUIT OF THE CATHETER. AS A RESULT, SIEMENS DEVICES ARE NOT COMPATIBLE WITH GE CONSOLES. THE CATHETERS WERE NOT RECOGNIZED AS A RESULT OF INCOMPATIBILITY BETWEEN THE DEVICES AND CONSOLE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, TWO ULTRASOUND CATHETERS "WERE NOT RECOGNIZED BY THE EQUIPMENT." APPROXIMATELY 50-60 MINUTES WERE SPENT TROUBLE SHOOTING BEFORE THE PROCEDURE WAS CANCELLED. THE PROCEDURE WAS RESCHEDULED FOR THREE DAYS LATER. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLI NLI STRYKER SUSTAINABILITY SOLUTIONS 08255790 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR