BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1218852 · Received October 31, 2008

    Report

    Report Number
    2021710-2008-00093
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 31, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON OCTOBER 6, 2008, 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 MANUFACTURER. (B) (4). (B) (4): THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A HILL-ROM (THIRD PARTY SERVICE CO) REP AND THE (B) (4) TEST DATA SHEET SUBMITTED TO CARDINAL HEALTH BY HILL-ROM (THIRD PART SERVICE CO). THE HILL-ROM (THIRD PARTY SERVICE CO) SERVICE TECH EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE THE REPORTED EVENT. THUS NO ROOT CAUSE WAS DETERMINED. THE HILL-ROM (THIRD PARTY SERVICE CO) SERVICE TECH RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT (B) (4) TO ENSURE THAT IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE RENTAL POOL READY TO BE PLACED BACK INTO RENTAL SERVICE. THIS FILE WILL BE CLOSED AT THIS TIME AND MAY BE REOPENED UPON THE RECEIPT OF ADDITIONAL INFO. NO COMPONENT OR SYSTEM TREND HAS BEEN IDENTIFIED, AND THIS IS CONSIDERED TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    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 REP. "TRANSFER FROM RENTALS. [NAME REMOVED] WAS VERY UPSET. SHE EXPLAINS THAT SHE HAS BEEN GETTING THE "RUN AROUND" FOR OVER 30 MINUTES NOW AND ALL SHE NEEDS TO DO IS REQUEST A REPLACEMENT FOR A "3100B BLENDER THAT HAS FAILED." SHE EXPLAINS THAT THE INO THERAPEUTICS O2 ANALYZER READS ONLY 75% WHEN THE BLENDER IS SET TO 100%. THEY PUT AN ANALYZER IN-LINE WITH THE BLENDER AND FOUND THAT THE BLENDER WAS NOT DELIVERING THE 100% THAT IT IS DIALED TO. SHE INSISTS THAT ALL THE HOSES ARE CORRECT AND THE BLENDER IS SET UP CORRECTLY ONTO THE 3100B. THE PT IS DOING OKAY (NO PT COMPROMISE), BUT THE DOCTORS WANT THE VENT REPLACED. I EXPLAINED ABOUT "COMPLAINTS" AND THAT TECH SUPPORT IS AVAILABLE 24/7. I WILL AUTHORIZE A REPLACEMENT AND NOTIFY RENTALS. (THERE WAS NO PAGER CALL THIS MORNING FROM THIS CUSTOMER)."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK