BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 3234109 · Received July 8, 2013

    Report

    Report Number
    2021710-2013-00052
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT PROVIDE ANY PATIENT OR DEVICE CODES ON THEIR USER FACILITY REPORT. CODES WERE DERIVED BASED ON THE INFORMATION PROVIDED BY THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE FDA ON (B)(4) 2013 AND INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST ON (B)(4) 2013 IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP AND THE CAREFUSION FACTORY SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY 3 OHM DRIVER ASSEMBLY. THE CAREFUSION FIELD SERVICE REP REPLACED THE 3 OHM DRIVER ASSEMBLY AND RAN THE DEVICE THROUGH A COMPLETE CHECKOUT PER THE OPERATOR'S AND SERVICE MANUALS TO ENSURE THAT THE DEVICE MEETS FACTORY SPECIFICATIONS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE USER FACILITY'S CONTROL READY TO BE PLACED BACK INTO SERVICE. THE ALLEGED FAULTY 3 OHM DRIVER ASSEMBLY WAS RECEIVED INTO THE CAREFUSION FACTORY SERVICE DEPARTMENT FOR EVALUATION. THE CAREFUSION FACTORY SERVICE REP EVALUATED THE FAULTY 3 OHM DRIVER ASSEMBLY AND DETERMINED THAT THE ROOT CAUSE OF ITS FAILURE WAS THAT ONE OF THE TINSEL WIRES INSIDE THE 3 OHM DRIVER ASSEMBLY HAD BROKEN RESULTING IN AN OPEN COIL. THIS IS A KNOWN ISSUE THAT HAS ALREADY BEEN ADDRESSED, NO ADDITIONAL INVESTIGATION/EVALUATION IS REQUIRED. THE CORRECTIVE AND PREVENTIVE MEASURES RESIDE WITHIN A CAREFUSION INTERNAL CORRECTIVE AND PREVENTIVE ACTION FILE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PATIENT WAS DOCUMENTED ON (B)(4) 2013 BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED AND NEEDS A SERVICE CALL ON THIS UNIT. HE SAID IT STOPPED RUNNING ON A PATIENT, ALARMED CORRECTLY. HE SAID THAT THE SETTING HE WAS GIVEN WERE POWER AT 7.0, 30LPM, IT.33, FZ 3.9. ADJUST KNOB AT 2 O'CLOCK POSITION. MAP HIGH ALARM AT 59CM, LOW ALARM AT 25CM. HE SAID THT HE CAN'T GET THE DRIVER TO START BUT THE UNIT PRESSURIZES FINE. HE SAID WHEN HE DEPRESSES THE START/STOP BUTTON THE LIGHT ON THE BUTTON IS RED AND THE UNIT ALARMS. HE STATED THAT THERE WAS NO PATIENT HARM, THE UNIT WAS SWAPPED OUT WITH ANOTHER 3100B UNIT. HE IS NOT SURE IF THEY SAW THE OVERHEAT LIGHT AT THE TIME, HE SAID IT WASN'T MENTIONED IN THE REPORT ETC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308989 SENSORMEDICS VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION 3100B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR ASKU / ASKU