BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 977633 · Received August 28, 2007

    Report

    Report Number
    2021710-2007-00052
    Event Type
    Malfunction
    Date Received
    August 28, 2007
    Date of Event
    April 13, 2007
    Report Date
    August 28, 2007
    Manufacturer
    VIASYS RESPIRATORY CARE INC
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED FAULTY DRIVER ASSEMBLY WAS RECEIVED INTO THE MANUFACTURING PLANT ON 7/13/07 AND IS CURRENTLY UNDERGOING EVAL. ADDITIONALLY, WE HAVE REQUESTED THE SERVICE HISTORY OF THE DEVICE FROM THE USER FACILITY AS IT PERTAINS TO THE ORIGINAL INSTALLATION OF THIS DRIVER ASSEMBLY INTO THE DEVICE AND ITS SUBSEQUENT REPLACEMENT BY THEM IN RESPONSE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE FDA ON 7/31/07. "UPON TURNING ON THE OSCILLATOR, IT SHUT DOWN SPONTANEOUSLY. THREE MORE ATTEMPTS TO START THE OSCILLATOR RESULTED IN AUTOMATIC SHUT DOWN. PROVIDERS NOTICED A BURNING SMELL COMING FROM THE OSCILLATOR WHICH WAS REPLACED WITH A NEW UNIT. THE PT WAS NOT HARMED." THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A VIASYS TECH SUPPORT SPECIALIST ON 4/16/07 IN RESPONSE TO PHONE CONVERSATION WITH A USER FACILITY REP. "CUSTOMER CALLED IN ABOUT UNIT OVERHEATING AND DRIVER STOPS OSCILLATING. CUSTOMER STATES THAT RESPIRATORY SAID THEY TOOK THE PT OFF UNIT DUE TO A PROCEDURE AND WHEN THEY WERE READY TO CONNECT BACK TO PT, UNIT WOULD NOT PRESSURIZE OR START AND THEY SMELLED SMOKE OR LIKE SOMETHING THAT WAS BURNING. UNIT WAS SENT DOWN TO BIOMED AND BIOMED WENT THROUGH THE PERFORMANCE CHECK AND PT CIRCUIT CALIBRATION. BIOMED STATED THAT HE COULD NOT DUPLICATE WHAT THERAPIST EXPERIENCED, AND EVERYTHING ON THE UNIT AT THE TIME CHECKED OUT, SO BIOMED PUT UNIT BACK INTO SERVICE. THE RESPIRATORY HAD THE UNIT ON ANOTHER PT AND DISCONNECTED PT TO DO A PROCEDURE, AND WHEN THE THERAPIST WAS READY TO PLACE PT BACK ON VENT UNIT WOULD NOT START BACK UP. SO RESPIRATORY SENT VENT TO BIOMED A SECOND TIME, BUT THIS TIME THEY DID NOT REPORT SMELLING SOMETHING THAT WAS BURNING. AS SOON AS BIOMED BEGIN TO INSPECT UNIT FOR A SECONG TIME UNIT HAD A SMOKEY SMELL. THE BIOMED GUY STATED THAT HE WAS ABLE TO START UNIT AND LET IT RUN AND AFTER A WHILE UNIT STOP OSCILLATING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS HIGH FREQUENCY OSCILLATORY VENT LSZ VIASYS RESPIRATORY CARE INC 3100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR