BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1518485 · Received October 15, 2009

    Report

    Report Number
    2021710-2009-00039
    Event Type
    Other
    Date Received
    October 15, 2009
    Date of Event
    August 26, 2009
    Report Date
    October 15, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MAP WOULD NOT ADJUST: THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE BY THE USER FACILITY WAS DOCUMENTED BY A CAREFUSION CUSTOMER ADVOCATE IN RESPONSE TO A PHONE CONVERSATION BETWEEN THE CAREFUSION CUSTOMER ADVOCACY MANAGER AND THE USER FACILITY BIOMEDICAL ENGINEERING DIRECTOR. PER A CONVERSATION BETWEEN CAREFUSION CUSTOMER ADVOCACY MANAGER AND THE USER FACILITY BIOMEDICAL ENGINEERING DIRECTOR. IT WAS IDENTIFIED THAT THIS DEVICE WAS REPAIRED BY REPLACING THE POINTER KNOB AND THEN RETURNED TO IN-SERVICE OPERATION. FURTHER, THE BIOMEDICAL ENGINEERING DIRECTOR AT THIS FACILITY STATED THAT THE ROOT CAUSE WAS DUE TO AGGRESSIVE USE BY THE RESPIRATORY STAFF. TO SUPPORT THE CUSTOMER, CAREFUSION HAS AGREED TO SEND SPARE POINTER KNOBS TO THIS CUSTOMER TO REPLACE DURING ROUTINE MAINTENANCE. EVEN THOUGH THIS EVENT FAILURE HAS BEEN IDENTIFIED AS A USER ERROR, WE HAVE INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST (CAR).

    Description of Event or Problem · 1

    (B)(4). "TITLE: XXXXX. EVENT DESC: DURING SET UP PRIOR TO CONNECTION TO PT, RESPIRATORY TECHNICIAN WAS UNABLE TO CALIBRATE MEAN CIRCUIT PRESSURE ON HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV). RESPIRATORY THERAPIST NOTED THAT THE MEAN PRESSURE ADJUST KNOB HAD TURNED PAST IT'S MECHANICAL STOP AND THE RT WAS UNABLE TO CALIBRATE VENTILATOR. VENTILATOR EXCHANGED AND SENT TO BIOMEDICAL FOR REPAIR." "VISUAL AND OPERATIONAL TEST ON (B)(6)2009: BIOMEDICAL NOTED THAT THE ADJUSTMENT KNOB POINTER WAS ALSO USED AS THE ADJUSTMENT STOP FOR THE KNOB IN THE 5 O'CLOCK MAXIMUM SETTING POINT. THE STOP POST IS A 2-56 THREADED SCREW EXTENDING FROM THE CONTROL PANEL. WHAT WE NOTED WAS THE KNOB POINTER WAS FORCED PAST THE STOP POST AND THE USER COULD NOT CALIBRATE THE VENTILATOR AFTER THAT POINT. THE KNOB CAN EASILY SLIP PAST THE STOP POST WITH LITTLE OR NO USER EFFORT. BIOMEDICAL TEMPORARILY THICKENED THE STOP POT BY ADDING A 1/8" LENGTH OF SHRINK TUBE OVER THE SCREW. THIS PREVENTED THE KNOB FROM SLIPPING PAST THE STOP POST. WE CONCLUDED THAT A MINOR DESIGN CHANGE MAY BE NEEDED TO PREVENT THE KNOB FROM GOING PAST THE MAX ADJUST POINT." "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET TO WORK OR STOPPED WORKING)". "DEVICE USAGE PROBLEM: DEVICE WAS HARD TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ, VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA