BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2096137 · Received May 12, 2011

    Report

    Report Number
    2021710-2011-00035
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR FROM (B)(4) INITIALLY REPORTED THAT THE DEVICE'S SERIAL NUMBER WAS (B)(4). CAREFUSION ASKED THAT THEY VERIFY THE SERIAL NUMBER OF THE DEVICE AND THEY REALIZED THAT THEY HAD REPORTED THE INCORRECT SERIAL NUMBER AND THAT THE CORRECT DEVICE SERIAL NUMBER WAS (B)(4). NEITHER THE FOREIGN USER FACILITY NOR THE FOREIGN DISTRIBUTOR SUBMITTED A USER FACILITY/IMPORTER REPORT TO THE MFR. THE CAREFUSION TECH SUPPORT SPECIALIST IN CONJUNCTION WITH THE DISTRIBUTOR IN (B)(4) DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY ALARM DELAY PWB. THE DISTRIBUTOR IN (B)(4) WAS SHIPPED A REPLACEMENT ALARM DELAY PWB TO REPAIR THE DEVICE AND RETURN IT TO THEIR CUSTOMER READY TO BE PLACED BACK INTO SERVICE. THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE ALLEGED FAULTY ALARM DELAY PWB AND WAS UNABLE TO REPRODUCE/VERIFY THE COMPLAINT. THUS NO ROOT CAUSE WAS DETERMINED. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS RESULTED IN ZERO VERIFIED LIKE FAILURES, THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFO CONCERNING THE EVENT WAS COPIED BY A CAREFUSION TECH SUPPORT SPECIALIST FROM AN E-MAIL FROM THE FOREIGN DISTRIBUTOR. "THE 3100B UNIT (B)(4) THAT WAS DELIVERED TO US IN SEPT 2010 HAS A TECHNICAL PROBLEM. OUR ENGINEER HAS INSPECTED AND FOUND THE ALARM SILENCE DOESN'T WORK. IT WON'T PRODUCE ALARM WHEN THE MACHINE WORKS ABNORMALLY, SO THE CUSTOMER THINKS IT'S UNRELIABLE TO USE WITHOUT THE ALARM. MY ENGINEER HAS TESTED IT WITH THE PWB ASSY ALARM DELAY UPGRADE FROM OUR DEMO UNIT, AND THE HFO WORKS NORMALLY NOW. IT CAN PRODUCE ALARM AS USUAL. THUS, I WOULD LIKE TO CLAIM THE PART: P/N 24-771401 PWB ASSY ALARM DELAY UPGRADE. I BELIEVE THIS UNIT IS STILL UNDER WARRANTY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA