BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2210207 · Received July 11, 2011

    Report

    Report Number
    2021710-2011-00051
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, CAREFUSION SENT A LETTER VIA E-MAIL TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PATIENT. AS OF JULY 11, 2011 THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE/VERIFY THE COMPLAINT. THUS NO ROOT CAUSE WAS DETERMINED. CAREFUSION HAS DETERMINED THAT BASED ON THE AGE OF THIS DEVICE IT IS NOT COST EFFECTIVE TO CONTINUE TO MAINTAIN IT AS A PART OF THE RENTAL POOL. THUS THE DEVICE WILL BE RETIRED FROM SERVICE AND SCRAPPED. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS RESULTED IN ZERO LIKE FAILURES, THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REPRESENTATIVE. "[NAME REMOVED] IN RT DEPT STATED THAT THIS UNIT WAS ON A PATIENT YESTERDAY AND EVERY TIME THEY WOULD TAKE THE PATIENT OFF THE VENT, TO SUCTION ETC., THE UNIT WOULD NOT ALARM. THEY REPLACED THE 9VOLT BATTERY THINKING THAT MIGHT HELP BUT IT DIDN'T. EXPLAINED TO HER THE 9 VOLT BATTERY IS FOR POWER FAILURE ONLY. SHE SAID THAT THEY SWAPPED THE UNIT OUT WITH ANOTHER 3100A, NO PATIENT COMPROMISE. THEY WOULD LIKE THIS UNIT PICKED UP AND REPLACED. WILL NOTIFY THE RENTAL GROUP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU