BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1476140 · Received September 10, 2009

    Report

    Report Number
    2021710-2009-00033
    Event Type
    Malfunction
    Date Received
    September 10, 2009
    Date of Event
    June 1, 2009
    Report Date
    September 10, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CARDINAL HEALTH POST MARKET QUALITY ASSURANCE DEPT. SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE STATUS OF THE PATIENT. AS OF THE DATE OF THIS REPORT, THE USER FACILITY HAS NOT RESPONDED TO THAT LETTER. THE USER FACILITY DID NOT PROVIDE ANY PATIENT OR DEVICE CODES ON THEIR USER FACILITY REPORT. (B)(4): THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE EVALUATIONS PERFORMED BY BOTH THE CARDINAL HEALTH FIELD SERVICE REP. AND CARDINAL HEALTH SERVICE DEPARTMENT. THE CARDINAL HEALTH FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND IDENTIFIED A SEIZED 3 OHM DRIVER (B)(4) AS THE ROOT CAUSE OF THE REPORTED EVENT. DURING THE FIELD SERVICE EVALUATION AND NOT RELATED TO THE REPORTED EVENT, THE TECHNICIAN NOTICE THAT THE 15 TURN KNOB (B)(4) WOULDN'T TURN SMOOTHLY AND NEEDED TO BE REPLACED. UPON ARRIVAL TO THE FACTOR, THE 3 OHM DRIVER WAS EVALUATED BY A CARDINAL HEALTH SERVICE DEPARTMENT TECHNICIAN, AND HE IDENTIFIED THAT THE DRIVER COIL (B)(4) WAS STUCK AT THE BOTTOM OF THE DRIVER BETWEEN THE POLE PIECE (B)(4) AND MAGNET PLATE (B)(4). THE TECHNICIAN OPENED THE DRIVER AND FOUND THAT SPIDER (B)(4) HAD TORN CAUSING THE COIL ASSEMBLY (B)(4) TO DETACH AND GRIND AGAINST THE POLE PIECE (B)(4). THE COIL ASSEMBLY WAS BURNED AND GOT STUCK BETWEEN THE MAGNET PLATES (B)(4) AND POLE PIECE (B)(4). THE CARDINAL HEALTH FIELD SERVICE ENGINEER REPLACED THE 3 OHM DRIVER, 15 TURN KNOB AND AS A PRECAUTION THE 9 VOLT BATTERY (B)(4) AND BOTH WATER TRAPS (B)(4) WERE REPLACED AS PART OF A 4K PM PERFORMED ON THE DEVICE. HE THEN RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. A REVIEW OF TRENDED COMPLAINTS FOR THE PASS 6 MONTHS DOES NOT REVEAL A TREND ASSOCIATED WITH THE 3 OHM DRIVER (B)(4), AT PRESENT, THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT. ADDITIONALLY, THIS FILE WILL BE TRENDED AS PART OF OUR MONTHLY TRENDED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. ON (B)(6) 2009: "[NAME REMOVED] PAGED. STATED THAT HE WOULD LIKE A SERVICE CALL ON THIS UNIT BECAUSE IT "STOPPED"." ON (B)(6) 2009: "[NAME REMOVED] CALLED BACK HE IS REQUESTING FSD, SECONDARY TO THE UNIT APPARENTLY SHUT DOWN WHILE ON A PATIENT PROPER ALARMS WERE FUNCTIONAL, THE PATIENT WAS PLACED ON CONVENTIONAL UNIT, [NAME REMOVED] HAD LITTLE DETAILS UNIT WAS NOT IN FRONT OF HIM, BUT NOTED THAT EARLIER WHEN HE POWERED THE UNIT UP, IT PRESSURIZED, BUT AFTER A FEW MINUTES, IT POWERED DOWN HE NOTED ELECTRICAL BURNT SMELL, [NAME REMOVED] WILL CALL BACK WITH SETTINGS I WILL DISPATCH CALL." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CARDINAL HEALTH (B)(4) FROM THE FDA AND THEN FORWARDED TO CARDINAL HEALTH 2007, INC. ON (B)(6) 2009. "EVENT DESC: STOPPED WORKING WHILE ON PATIENT. WIDE FLUCTUATIONS IN MAP (80-140'S). PISTON MAKING A WEIRD NOISE. CHANGED CIRCUIT AND BELLOW AND DIAPHRAGM SET. NO CHANGE. PULLED FROM PATIENT. PLACED PATIENT ON CONVENTIONAL VENTILATOR WITH APPROPRIATE SETTINGS. SATS DROPPED TO 83%. PATIENT RECOVERED WITH SATS IN THE LOW 90'S." "DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO" "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)". THE FOLLOWING DEVICE EVALUATION PERFORMED BY THE USER FACILITY WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CARDINAL HEALTH (B)(4) FROM THE FDA AND THEN FORWARDED TO CARDINAL HEALTH 2007, INC ON 08/12/2009. THIS USER FACILITY EVALUATION WAS PERFORMED AFTER THE CARDINAL HEALTH FIELD SERVICE ENGINEER WENT ON SITE ON 06/05/2009 TO REPAIR THE DEVICE FOR THE EVENT THAT OCCURRED ON (B)(6) 2009. BASED ON THE USER FACILITY EVALUATION PERFORMED ON 06/17/2009, THE DEVICE WAS OPERATING AS INTENDED. THE END USER FAILED TO REALIZE THAT THE VENT'S AUTO-LIMIT FEATURE WAS ACTIVATED. ONCE THE MAP WAS BROUGHT DOWN BELOW THE SET MAX PAW ALARM SETTING, THE MAP STABILIZED. "PERFORMED TESTING ON 6/17/2009: PLACED TEST CIRCUIT ON UNIT AND POWER ON. NOTED FOLLOWING PATIENT SETTINGS: POWER: 4.8, BIAS FLOW: 42 LPM, MEAN PRESSURE ADJUST KNOB: 3 O'CLOCK POSITION, INSP TIME: 3.2, FREQUENCY: 4.6, HIGH PRESSURE LIMIT: 50, LOW PRESSURE LIMIT: 10. NOTED WHEN CIRCUIT PRESSURED THAT WITH THE ABOVE SETTINGS OVER-PRESSURIZATION WAS OCCURRING AND CIRCUIT WOULD DUMP EXCESS PRESSURE. UPON INITIATING THE OSCILLATION NOTED THAT THE DRIVER WOULD RAMP UP UNTIL OVER-PRESSURIZATION OCCURRED AT WHICH TIME THE DRIVER APPEARED TO REDUCE IN POWER DUE TO THE PRESSURE DUMP FROM THE CIRCUIT. WIDE VARIATIONS IN MEAN PRESSURE AND POWER WERE NOTED. THE MEAN PRESSURE ADJUST WAS REDUCED TO APPROX 2 O'CLOCK SETTING WHICH ELIMINATED THE OVER-PRESSURIZATION IN THE CIRCUIT. THE WIDE VARIATIONS IN MEAN PRESSURE AND POWER SMOOTHED OUT AND WERE STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ, VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR