BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1456895 · Received August 25, 2009

    Report

    Report Number
    2021710-2009-00034
    Event Type
    Other
    Date Received
    August 25, 2009
    Date of Event
    July 27, 2009
    Report Date
    August 25, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURE. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. BASED ON THE EVAL PERFORMED BY THE USER FACILITY, CARDINAL HEALTH HAS DETERMINED THAT THIS EVENT WAS CAUSED BY A USER ERROR. THE INPUT AND OUTPUT OF THE AIR/O2 BLENDER WERE REVERSED. THE USER FACILITY REP CORRECTED THE HOSE CONFIGURATION PRIOR TO RETURNING THE DEVICE TO USE. THROUGH COMMUNICATION WITH CARDINAL HEALTH TECH SUPPORT SPECIALIST AND HILL-ROM (3RD PARTY RENAL FACILITY) THIS DEVICE WAS SET UP BY THE USER FACILITY AND NOT CARDINAL HEALTH OR HILL-ROM. PER HILL-ROM THEY TEST THEIR DEVICES TO ENSURE THEY MEET ALL FACTORY SPECS WHICH INCLUDES AN FIO2 ACCURACY TEST. ONCE THE VERIFICATION IS COMPLETE THE AIR/O2 BLENDER HOSES ARE REMOVED FROM THE AIR/O2 BLENDER AND PUT IN A BAG FOR SHIPPING. IT IS THE USER FACILITY RESPONSIBILITY TO CONNECT THE AIR/O2 BLENDER HOSES IN THE CORRECT CONFIGURATION AS STATED IN THE OPERATORS MANUAL. THE O2 AND AIR INPUT ON THIS AIR/O2 BLENDER ARE CLEARLY LABELED AS SUCH AND HAD AN O2 ANALYZER BEEN USED AS PER OUR LABELING THE END USER WOULD HAVE IDENTIFIED THE O2 INACCURACY.

    Description of Event or Problem · 1

    [THIS RENTAL DEVICE WAS SET UP BY THE USER FACILITY AND NOT CARDINAL HEALTH OR HILL-ROM (3RD PARTY RENTAL FACILITY).] THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. CALLED TO REQUEST PICKUP OF THE TWO RENTAL 3100BS. SHE ALSO WANTED TO REPORT A PROBLEM FOUND WITH THEM. BOTH OF THEM WERE FOUND TO DELIVER 100% FIO2. SHE STATED THAT THEY FOUND THAT THE "INPUT AND OUTPUT" OF THE BLENDER WERE REVERSED. LUCKILY THEY FOUND THIS DURING THE INITIAL SET UP ON THE PT SO THEY WERE ABLE TO CORRECT THE PROBLEM BEFORE THE PT WAS ON 100% FOR VERY LONG. I EXPLAINED TO HER ABOUT THE SPI CHECKOUT THAT IS DONE BEFORE DELIVERY AND THAT IT DOES INCLUDE A FIO2 CHECK".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK