BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSORMEDICS

    MDR report key: 1479013 · Received September 18, 2009

    Report

    Report Number
    2021710-2009-00036
    Event Type
    Death
    Date Received
    September 18, 2009
    Date of Event
    August 20, 2009
    Report Date
    September 18, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. THE CARDINAL HEALTH POST MARKET QUALITY ASSURANCE DEPARTMENT SENT AN EMAIL TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. THE EMAIL SPECIFICALLY REQUESTED INFORMATION CONCERNING THE PRIMARY AND SECONDARY CAUSES OF DEATH. AS OF THE DATE OF THIS REPORT, THE USER FACILITY HAS NOT RESPONDED TO THAT EMAIL. THEREFORE, CARDINAL HEALTH IS NOT ABLE TO DETERMINE IF THE REPORTED FAILURE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. CARDINAL HEALTH WILL CONTINUE REQUESTING ADDITIONAL INFORMATION FROM THE USER FACILITY IN ORDER TO COMPLETE AND SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    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 REPRESENTATIVE. IN 2009: "[NAME REMOVED] RESPIRATORY MANAGER WAS TRANSFERRED BY RENTALS, HE CALLED TRYING TO GET A HOLD OF CLINICAL SPECIALIST FOR CLINICAL INPUT FOR PATIENT ON 3100B/AND GET A RENTAL 3100B [NAME REMOVED]. NOTED THERE WAS AN ISSUE WITH THE UNIT THOUGH HE DID NOT HAVE DETAILS HE WOULD HAVE THERAPIST ASSIGNED TO CALL WITH DETAILS." THE SAME DAY: "THE THERAPIST ASSIGNED CALLED NOTING THAT THE UNIT PASSED THE PATIENT CIRCUIT CAL/PERFORMANCE VERIFICATION, BUT AFTER IT WAS PLACED ON THE PATIENT NO MORE THAN 2 MINUTES, THE ADJUST KNOB WAS NOT RESPONSIVE. IT FELT LOOSE. UNFORTUNATELY, THE PATIENT EXPIRED SECONDARY TO CARDIAC ARREST PER [NAME REMOVED] WITHIN THE 2 MINUTES OF USE. SETTINGS MAP 39, AMP'84, FIO2 100%, HZ6 IT.5. NOTED THE PATIENT HAD BEEN ON A CONVENTIONAL UNIT WITH MAX SETTINGS VOLUME MODE." THE CARDINAL HEALTH POST MARKET QUALITY ASSURANCE DEPARTMENT SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. THE LETTER SPECIFICALLY REQUESTED INFORMATION CONCERNING THE PRIMARY AND SECONDARY CAUSES OF DEATH. AS OF THE DATE OF THIS REPORT, THE USER FACILITY HAS NOT RESPONDED TO THAT LETTER.

    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 20 YR Death