BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2083365 · Received April 20, 2011

    Report

    Report Number
    2021710-2011-00029
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 19, 2011
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SVC REP AND THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE CAREFUSION FIELD SVC REP EVALUATED THE DEVICE AND WAS NOT ABLE TO REPRODUCE/VERIFY THE COMPLAINT OF THE DEVICE STOPPING ON ITS OWN AND TRIPPING THE CIRCUIT BREAKER (POWER SWITCH). THE CAREFUSION FIELD SVC REP FOUND THAT AFTER RUNNING THE DEVICE FOR APPROX 2 HOURS HE COULD SMELL SOME HEAT ODOR EMANATING FROM THE DRIVER ASSEMBLY. THE CAREFUSION FIELD SVC REP REPLACED THE DRIVER ASSEMBLY AND RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION, THE UNIT WAS RETURNED TO THE CUSTOMER'S CONTROL READY TO BE PLACED BACK INTO SVC. THE CAREFUSION ANALYSIS LAB TECH EVALUATED THE ALLEGED FAULTY DRIVER ASSEMBLY AND VERIFIED THE COMPLAINT. THE CAREFUSION FAILURE ANALYSIS LAB TECH DETERMINED THAT THE ROOT CAUSE OF THE DRIVER ASSEMBLY'S FAILURE WAS THAT THE COIL ASSEMBLY PN: (B)(4) WAS OUT OF ALIGNMENT AND RUBBING AGAINST THE POLE PIECE PN: (B)(4). THE CAREFUSION FAILURE ANALYSIS LAB TECH WAS UNABLE TO DETERMINE WHAT CAUSED THE COIL ASSEMBLY TO BE OUT OF ALIGNMENT. A REVIEW OF THE CAREFUSION COMPLAINT SYS FOR THE PAST 90 DAYS DID NOT FIND ANY VERIFIED LIKE FAILURES, THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED TO REPORT THAT OVER THE WEEKEND (SATURDAY 10:00 PM), THIS VENTILATOR JUST "FAILED ON A PT". SHE EXPLAINED THAT IT WAS RUNNING FINE ALL DAY ON A PT (SETTING: MAP 30, POWER 10, 3HZ) WHEN ALL OF A SUDDEN THEY STARTED SMELLING SOMETHING "BURNING" AND THEN WENT TO THE VENT WHEN THE ALARMED INDICATING THAT IT HAD STOPPED. THERE WAS NO "OVERHEAT" LIGHT PRESENT, BUT THEY DID NOTICE THAT THE VENTILATOR FELT VERY HOT TO THE TOUCH. THEY COULD NOT RESTART THE VENT, BUT THEY WERE ABLE TO PRESSURIZE THE UNIT. THEY QUICKLY ATTENDED TO THE PT, HANDBAGGED AND SWITCHED THE PT THE ANOTHER VENTILATOR." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED BY THE CAREFUSION FIELD SVC REP FROM THE RESPIRATORY THERAPIST'S REPORT OF THE INCIDENT." NOTES FROM RT [NAME REMOVED] TO [NAME REMOVED] (B)(6) 2011: "[NAME REMOVED], THE FOLLOWING IS MY ACCOUNT OF WHAT HAPPENED THIS EVENING. DURING SHIFT CHANGE REPORT THERE WAS NOTHING UNUSUAL REPORTED TO ME BY RT OR BY THE NURSES ON THE UNIT UPON MY ARRIVAL. MY 21:00 VENT CHECKS WERE COMPLETED WITH ALL SETTINGS AND VALUES WITHIN NORMAL LIMITS. APPROX 21:00, A CODE BLUE WAS CALLED IN CCU. UPON OUR ARRIVAL TO THE UNIT, A NURSE WAS ADMINISTERING BAG VALVE VENTILATIONS TO THE PT AND THE OSCILLATOR WAS TURNED OFF. THE PT'S SPO2 WAS 91% AND THERE WAS ADEQUATE HEART RHYTHM. THE OSCILLATOR WAS CHIRPING SHORT CHIRPS. THERE WAS NO OTHER INDICATION OF ANY POWER TO THE VENTILATOR. THE POWER BUTTON WAS IN THE OFF POSITION. I QUESTIONED THE NURSE AS TO WHO TURNED OFF THE VENT, AND SHE STATED THAT NO ONE WAS IN THE ROOM AT THE TIME AND SHE ENTERED THE ROOM UPON HEARING THE ALARM AND FOUND IT IN THAT CONDITION. SHE IMMEDIATELY STARTED BAGGING THE PT. THE INTENSIVIST WAS AT THE BEDSIDE AT THIS TIME. I TURNED THE POWER BACK ON THE TO THE VENT AND IT APPEARED TO POWER UP NORMALLY. THE PT WAS PLACED BACK ON THE OSCILLATOR AND WITHIN 15 SECONDS, THE VENTILATOR ALARMED AND ALL POWER SHUT OFF. THE PT WAS REMOVED FROM THE VENT AND BAGGED AGAIN, WITH THE SPO2 NEVER DROPPING BELOW 91%. THE POWER WAS ACTIVATED AGAIN AND THE VENT STARTED UP AND STOPPED ON ITS OWN. AT THIS TIME, THE VENT WAS REPLACED WITH A SERVO I, SETTING AS PER MD. THE OSCILLATOR CIRCUIT WAS DISCONNECTED AND BAGGED, DUE TO THE PT BEING ON AIRBORNE PRECAUTIONS. THE VENT WAS TRANSPORTED BACK TO THE RESP DEPT AND TAKEN OUT OF SVC. BY THIS TIME YOU HAD BEEN CALLED AND WERE ADVISED OF THE SITUATION."

    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 46 YR Other