BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2883430 · Received November 14, 2012

    Report

    Report Number
    2021710-2012-00103
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, (B)(4) SENT A LETTER TO THE USER FACILITY ((B)(6)) SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. 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 MANUFACTURER. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO PROVIDED BY OUR DISTRIBUTOR (B)(4) VIA E-MAIL. THE (B)(4) FIELD SERVICE REP EVALUATED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORT OF NO AUDIBLE ALARM HOWEVER WAS ABLE TO CONFIRM THAT THE DEVICE WOULD NOT OSCILLATE. THE (B)(4) FIELD SERVICE REP DETERMINED THE ROOT CAUSE FOR DEVICE NOT OSCILLATING WAS A FAULTY DRIVER ASSEMBLY. THE ALLEGED FAULTY DRIVER ASSEMBLY WAS RECEIVED BY CAREFUSION ON (B)(4) 2012, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVAL. ONCE THE EVAL IS COMPLETE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY DISTRIBUTOR (B)(4) AND SENT TO CAREFUSION TECH SUPPORT VIA E-MAIL: "3100 STOPPED OSCILLATING WHILE ON A PT. 'OSC STOPPED' LED DID LIGHT. RT'S WERE AT THE BEDSIDE AND INTERVENED. NO AUDIBLE ALARM REPORTED. NO OVERHEAT LED REPORTED. [NAME REMOVED, USER FACILITY REP], TESTED THE DEVICE OFF PT. HE IS ABLE TO PASS A CIRCUIT CALIBRATION, BUT THE OSCILLATOR WILL NOT START. AUDIBLE ALARM IS TESTED AND FUNCTIONAL. WHEN [NAMED REMOVED] PUSHES IN THE FRONT PLATE IT IS HARD TO MOVE AND MAKES SMALL SCREECHING NOISE."

    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 ASKU