BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1915367 · Received November 18, 2010

    Report

    Report Number
    2021710-2010-00056
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    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

    NEITHER THE FOREIGN USER FACILITY NOT THE FOREIGN DISTRIBUTOR SUBMITTED A USER FACILITY/IMPORTER REPORT TO THE MFR. (B)(4): CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY ALARM DELAY PWB FOR EVALUATION. AS OF (B)(4), 2010, THE ALLEGED FAULTY ALARM DELAY PWB HAS NOT BEEN RECEIVED BY CAREFUSION. ONCE THE EVALUATION OF THE ALARM DELAY PWB IS COMPLETE, CAREFUSION WILL SUBMIT A FOLLOW-UP TO MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTIONS OF THE EVENT WERE DOCUMENTED/COPIED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO E-MAILS FROM THE FOREIGN DISTRIBUTOR. "[NAME REMOVED] E-MAILED COMPLAINT OF THIS MARKETING STUDY (B)(4). COMPLAINT: THE HIGH AND LOW PRESSURE ALARMS ARE NOT SOUNDING WHEN REACHED- DUMP VALVE ALWAYS INFLATES. SHE REQUESTS A REPLACEMENT ALARM BOARD (B)(4). I WILL HAVE THIS BOARD RETURNED UNDER (B)(4) AND SEND A REPLACEMENT. (B)(4) (I WILL E-MAIL [NAME REMOVED] FOR A BETTER DESCRIPTION OF THE COMPLAINT)." "[NAME REMOVED] (CLINICAL SUPPORT SPECIALIST) E-MAILED WITH ADDITIONAL DETAILS. THE "LOW PRESSURE" ALARMED, BUT NOT THE "<5CMH2O" ALARM. "HI (B)(4), THE TWO OSCILLATE 3100B'S AT (B)(6) THAT REQUIRED SERVICE WERE NOT ON PATIENTS AT THE TIME THAT I REPORTED THE ISSUES TO CARDINAL HEALTH'S SERVICE DEPARTMENT. I WAS SUSPICIOUS OF THIS VENTILATOR BECAUSE I NOTICED THAT WHEN I SWITCHED THE POWER ON THE CIRCUIT PRESSURIZED WITHOUT ME HAVING TO TOUCH THE RESET/POWER FAIL BUTTON. WHEN I DISCONNECTED THE CIRCUIT AT THE PATIENT "Y" THE AIRWAY PRESSURE DID NOT FALL TO <5CMH2O TO TRIP THE ALARM, PRESSURE STAYED AT 7-8 CM H2O WITH THE CIRCUIT OPEN. THERE WAS A LOW AIRWAY PRESSURE AUDIBLE/VISUAL ALARM FUNCTIONING. WHEN I TOOK OFF THE DUMP CAP-DIAPHRAGM THE BALLOON ALMOST POPPED. THERE WAS FLOW COMING THROUGH THE RED TUBING CONTINUOUSLY. (THIS IS WHAT [NAME REMOVED] ASKED ME TO VERIFY FOR HIM TO HELP TROUBLESHOOT OVER THE PHONE).""

    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