BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSORMEDICS

    MDR report key: 1194403 · Received October 10, 2008

    Report

    Report Number
    2021710-2008-00087
    Event Type
    Death
    Date Received
    October 10, 2008
    Date of Event
    July 23, 2008
    Report Date
    October 9, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 STATUS OF THE PT. THE USER FACILITY RESPONDED THAT THE PT HAD EXPIRED IN 2008; HOWEVER, THE MD DOES NOT THINK THIS EVENT CONTRIBUTED TO THE DEATH. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE AND FROM A FAX RECEIVED ON 9/15/2008 FROM THE USER FACILITY THAT WAS IN RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFO. THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH FIELD SERVICE REP. "THE CARDINAL HEALTH FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE, THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. THE FIELD SERVICE ENGINEER PERFORMED A DDI AND SPAN ADJUSTMENT, CHECKED POWER SUPPLIES, CHECKED PRESSURE AND EVERYTHING LOOKED FINE. HE THEN CHECKED DRIVER FOR 40 VOLT PEAK TO PEAK, RESET ALL CONNECTORS, TESTED ALARMS AND EVERYTHING WORKED CORRECTLY. PER FIELD SERVICE ENGINEER, MOST LIKELY THE CUSTOMER LOST PRESSURE ON PT CAUSING DEVICE TO STOP. DEVICE FUNCTIONED CORRECTLY AT MANY DIFFERENT LEVELS OF PRESSURE. THE CARDINAL HEALTH FIELD SERVICE ENGINEER RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. NO COMPONENT AND SYMPTOM TREND HAS BEEN IDENTIFIED AND THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT."

    Description of Event or Problem · 1

    IN 2008, A USER FACILITY REPRESENTATIVE CALLED IN TO CARDINAL HEALTH TECH SUPPORT TO DISCUSS AN EVENT THAT OCCURRED AT THE USER FACILITY ON THE PREVIOUS MONTH. THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY THE CARDINAL HEALTH TECH SUPPORT SPECIALIST. "[NAME REMOVED] CALLED AND SHE STATED THAT SHE WOULD LIKE TO HAVE THIS UNIT CHECKED OUT BY REP FROM OUR COMPANY. SHE STATED THAT THERE WAS AN "INCIDENT" ON A PT. SHE STATED THAT THE UNIT WAS WORKING, THEN STOPPED OSCILLATING AS WELL AS THE PRESSURE WAS LOST. THE MDS BAGGED THE PT, AND SHE IS UNSURE IF THEY REPLACED IT WITH ANOTHER OSCILLATOR OR CONVENTIONAL VENT. SHE IS ASSUMING THEY SWAPPED IT OUT WITH ANOTHER OSCILLATOR. I ASKED IF SHE HAD ANY SETTINGS OR ANY OTHER INFO. SHE STATED THAT SHE DOES NOT HAVE ANYMORE INFO SUCH AS SETTINGS ETC. SHE STATED THAT THE BIOMED DEPT LOOKED AT THE UNIT AND COULD NOT DUPLICATE THE PROBLEM. SHE IS IN THE CLINICAL ENGINEERING QA DEPT. SHE WANTED TO KNOW IF THIS COULD BE RELATED TO THE POWER MODULE THAT WAS REPLACED ON THIS UNIT IN 2007. I EXPLAINED TO HER AT THAT TIME THE COMPLAINT WAS THAT THE UNIT WOULD NOT START, AND THERE WAS NO LOSS OF PRESSURE. I THEN EXPLAINED TO HER THAT SHE STATED THAT ON THE COMPLAINT, THE PRESSURE WAS LOST. SHE ALSO DOES NOT HAVE THE HOURS ON THE UNIT. AT THE TIME OF THE POWER MODULE BEING REPLACED IN THE SAME MONTH, IT HAD 2043 HRS. SHE STATED THAT SHE IS THE CONTACT FOR THE SERVICE CALL, BUT WILL HAVE TO CONTACT THE BIOMED DEPT TO GET THE PO# READY FOR THE FIELD REP. SHE DID STATE THAT THE INCIDENT HAPPENED IN 2008. WILL DISPATCH A SERVICE CALL ON THIS UNIT FOR IT TO BE "CHECKED OUT." THE FOLLOWING EVENT DESCRIPTION WAS COPIED FROM A FAX RECEIVED ON 9/15/2008 FROM THE USER FACILITY THAT WAS IN RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND STATUS OF THE PT. "ON THAT DAY AT 12:15 PM, THE OSCILLATOR ON THE PT WHICH WAS WORKING, STOPPED WORKING AND LOST ALL PRESSURES. MD BAGGED PT. W/100% O2 & RESPIRATORY CARE CALLED TO SCENE. EXPIRED THE SAME DAY. MD DOES NOT THINK THIS EVENT CONTRIBUTED TO DEATH."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death