BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSORMEDICS

    MDR report key: 1241483 · Received November 21, 2008

    Report

    Report Number
    2021710-2008-00101
    Event Type
    Death
    Date Received
    November 21, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 19, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/27/2008, CARDINAL HEALTH SENT A LETTER VIA FAX TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE REPORTED EVENT AND PT EXPIRATION. SINCE THE USER FACILITY DID NOT RESPOND TO THE FIRST LETTER SENT VIA FAX ON 10/27/2008 A SECOND LETTER REQUESTING ADD'L INFO WAS SENT TO THE USER FACILITY ON 11/05/2008. 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 MFR. EVENT CODES WERE DERIVED BASED UPON INFO DOCUMENTED BY CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. AT THIS TIME, THE USER FACILITY IS NOT RELEASING THE DEVICE TO OUR RENTAL LOGISTICS DEPT IN ORDER TO HAVE (3RD PARTY SVC CO.) PICK UP THE DEVICE AND PERFORM AN EVAL. CARDINAL HEALTH TECH SUPPORT IS WORKING THROUGH OUR RENTAL LOGISTICS DEPT IN ORDER TO GET THE USER FACILITY TO RELEASE THE DEVICE FOR EVAL.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAMED REMOVED] PAGED. SHE WANTED TO REPORT A RENTAL 3100B "FAILURE". I CALLED HER BACK. SHE EXPLAINED THAT YESTERDAY, WHILE ON A PT, THE 3100B SUDDENLY LOST PRESSURE (DROPPED FROM 46CMH2O TO 10) AND THE DRIVER STOPPED (ALARMED APPROPRIATELY). THEY WERE UNABLE TO ESTABLISH PRESSURE SO THEY QUICKLY TOOK THE PT OFF THE 3100B AND PLACED HIM ON A CONVENTIONAL VENT. (THEY DO NOT OWN ANY 3100BS, AND DID NOT HAVE A BACKUP). THIS PT HAS BEEN VERY UNSTABLE AND THIS MORNING, THE PT DIED WHILE ON THE CONVENTIONAL VENT. [NAMED REMOVED] (SUPERVISOR) EXPLAINED THAT WHEN SHE CAME IN THIS MORNING, SHE HEARD WHAT HAD HAPPENED, AND WENT TO EVALUATE THIS RENTAL VENT. SHE FOUND THAT SHE HAD NO PROBLEMS PRESSURIZING THE SYSTEM. SHE REPORTS THAT THE VENT HAS NOW BEEN TAKEN FROM HER TO THEIR RISK MGMT FOR A COMPLETE EVAL. SHE EXPLAINED THAT SHE CONTACTED CLINICAL SPECIALIST [NAMED REMOVED] AND HE IS THE ONE WHO TOLD HER TO CALL THIS INCIDENT IN. I EXPLAINED TO HER ABOUT THE 3100B AND "LEAKS" (CAP DIAPHRAGM PROBLEMS). NO REPLACEMENT IS NECESSARY. SHE WILL CALL RENTALS WHEN THE VENTILATOR HAS BEEN RELEASED."

    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 Death