BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 912596 · Received September 14, 2007

    Report

    Report Number
    2021710-2007-00067
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 18, 2007
    Report Date
    September 14, 2007
    Manufacturer
    VIASYS RESPIRATORY CARE INC
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. A LYN MEDICAL (THIRD PARTY SERVICE COMPANY) FIELD SERVICE REP HAS BEEN DISPATCHED TO THE USER FACILITY TO EVALUATE AND REPAIR THE DEVICE. AS OF THE DATE OF THIS REPORT, THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A VIASYS TECH SUPPORT SPECIALIST RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[USER FACILITY REP] PAGED BECAUSE THIS UNIT WONT START. SHE SAID IT WAS RUNNING ON A PT AND IT SHUT DOWN AND ALARMED. THEY IMMEDIATELY BAGGED THE PT AND TRIED TO GET THE UNIT TO START AGAIN BUT IT WOULDN'T. THE UNIT PRESSURIZES FINE, BUT THE OSCILLATOR WON'T START. THE SETTINGS AT THE TIME WERE HZ 10, IT 33, AMPS 45, MAP 14, BIAS FLOW 20LPM, PT WAS ALSO ON NITRIC OXIDE. SHE WAS ABLE TO VERIFY THE COMPLAINT OFF OF THE PT. SHE CAN GET THE UNIT TO PRESSURIZE FINE, BUT WHEN SHE DEPRESSES THE START/STOP BUTTON THE UNIT DOES NOT START. SHE WANTED TO KNOW IF THERE WAS ANYTHING ELSE SHE COULD DO. I EXPLAINED TO HER THAT BASED ON WHAT SHE'S TELLING ME, SHE NEEDS TO HAVE THE UNIT LOOKED AT BY BIOMED. SHE UNDERSTOOD." THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM A LETTER FROM THE USER FACILITY THAT WAS IN RESPONSE TO A LETTER SENT BY VIASYS REQUESTING ADDITIONAL INFO. "UNIT STOPPED OSCILLATING. WHEN TO BEDSIDE, TRIED TO RESTART UNIT, UNABLE TO, INFANT DISCONNECTED FORM VENT, ALARM WENT OFF THEN, BAGGED INFANT UNTIL UNIT WAS REPLACED. ALARM DID NOT SOUND UNTIL INFANT DISCONNECTED. STILL ON VENTILATOR SUPPORT. PT CAME OFF OSC [OSCILLATOR] IN 2007, PLACED ON SERVO I."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA BLENDER - BIRD| PULSE OXIMETER - NELLCOR| HUMIDIFIER - F-PAYKEL| INO VENT