BEUDAMED
    FDA Adverse Event Death Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5412112 · Received February 4, 2016

    Report

    Report Number
    2021710-2016-02839
    Event Type
    Death
    Date Received
    February 4, 2016
    Report Date
    July 17, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL REPORT WAS IDENTIFIED AS A LATE SUBMISSION DURING A TWO YEAR RETROSPECTIVE REVIEW OF COMPLAINTS AND MDR¿S FOLLOWING RECEIPT OF AN UNTITLED LETTER ISSUED BY THE FDA. DATE OF EVENT WAS NOT DETAILED. (B)(4). THE UNIT RETURNED TO CAREFUSION FAILURE ANALYSIS LAB FOR EVALUATION. CAREFUSION SERVICE RECORDS FOR THIS UNIT WERE REVIEWED AND FOUND NO INDICATIONS THAT THE COVER HAD BEEN REPLACED. ALSO, FOUND NO INDICATION THAT THE COVER WAS INCORRECT OR THAT THE LABELING ON THE COVER WAS INCORRECT. EXAMINED (B)(4) RECORDS AND FOUND THAT THE LAST SPI PERFORMED ON THIS UNIT WAS ON 23 OCT 2012. HOWEVER, THE UNIT¿S TOP COVER HAS AN SPI LABEL FROM (B)(4) STATING IT WAS SERVICED ON 24 DEC 2012. EXAMINED VENT 3100B, P/N: 773967, S/N: (B)(4) AND FOUND THAT THE LABEL ON THE COVER, ¿LABEL, VENTILATOR PERFORMANCE CHECKS, 3100B¿ P/N: 767165 IS A REVISION H ¿767165-101H¿. REVISION H WAS USED BETWEEN 6 AUG 2002 AND 13 APR 2004. THIS LABEL INSTRUCTS THE USER, IN STEP # 4 TO, ¿SET MAX PAW ALARM TO 35 CMH2O.¿ THE CURRENT REVISION L ¿767165-101L¿ DOES NOT HAVE A MAX PAW SETTING INSTRUCTION. LOOKED AT REVISION HISTORY OF ¿LABEL, VENTILATOR PERFORMANCE CHECKS, 3100B ¿¿ P/N: 767165 AND FOUND THAT THE STEP # 4 INSTRUCTION, TO SET THE MAX PAW TO 35 CMH2O WAS REMOVED ON AN INTERNAL METHOD. THIS WAS RELEASED ON 22 JUN 2005 CHANGES THE REVISION OF LABEL P/N: 767165 FROM J TO K. UNITS BUILT AFTER 22 JUN 2005 SHOULD HAVE A LABEL ¿LABEL, VENTILATOR PERFORMANCE CHECKS, 3100B ¿¿ P/N: 767165 WITHOUT A SET MAX PAW TO 35 CMH2O INSTRUCTION. PER NAME PLATE LABEL, THIS UNIT WAS MANUFACTURED IN AUG OF 2005. THAT WOULD MEAN THAT IT WAS MANUFACTURED AFTER THE RELEASE DATE OF 22 JUN 2005. THUS, THE COVER ON THIS UNIT, WHICH CONTAINS OLD NO LONGER USED INSTRUCTIONS, DOES NOT BELONG TO THIS UNIT. ATTACHED A PATIENT CIRCUIT TO THE VENT AND FOUND THAT THE VENT FUNCTIONS NORMALLY. VENT FUNCTIONED NORMALLY DURING THE PERFORMANCE CHECK, DURING THE PATIENT CIRCUIT CALIBRATION AND DURING A 2 DAY SYSTEM VERIFICATION RUN. THE UNIT, IF SETUP PER THE VENTILATOR PERFORMANCE CHECKS LABEL P/N: 767165 REV. H AND THEN STARTED WOULD GO INTO THE HIGH MAX PAW 35 CMH2O ALARM. HOWEVER, BY ADJUSTING THE BIAS FLOW DOWN IT COULD BE TAKEN OUT OF THIS ALARM AREA. THE SAME IS TRUE OF THE PATIENT CIRCUIT CALIBRATION. IT WAS FOUND THAT IN BOTH CASES PRIOR TO MAKING THE BIAS FLOW ADJUSTMENT THE UNIT¿S PAW WOULD FLUCTUATE AS THE PRESSURE WOULD ALTERNATELY EXCEED THE MAX PAW AND THEN DUMP PRESSURE AND RECOVER. COULD NOT DUPLICATE THE REPORTED CONDITION OF, ¿FAILS TO PRESSURIZE DURING THE PERFORMANCE CHECK ISSUE¿. FOUND THAT THE COVER IS OLD AND DOES NOT BELONG TO THIS UNIT AND THUS, LABEL, VENTILATOR PERFORMANCE CHECKS 3100B P/N: 767165 REV. H IS OLD AND HAS DISCONTINUED INSTRUCTIONS ON IT. IN REVIEWING THE SERVICE HISTORY RECORD OF THIS UNIT IT COULD NOT BE DETERMINED HOW THIS OLDER COVER WAS PUT ON THIS UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE FACILITY HAS A PROBLEM WITH THEIR NEWLY DELIVERED RENTAL VENT (S/N (B)(4)). CUSTOMER EXPLAINED THE UNIT FAILS TO PRESSURIZE DURING THE PERFORMANCE CHECK, BUT IT PRESSURIZES FINE DURING THE PATIENT CIRCUIT CALIBRATION. THE CAREFUSION REPRESENTATIVE SUSPECTED THE CUSTOMER REQUIRED ASSISTED WITH THE AUTO LIMIT FEATURE AND ASSISTED THE END USER WITH PROCEDURES AND TECHNICAL ASSISTANCE REGARDING THE MAX PAW THUMBWHEEL. HOWEVER THE END USER REPORTED THE UNIT WAS STILL NOT PRESSURIZING (ONLY PRESSURIZED TO 21). AFTER ADDITIONAL TECHNICAL ASSISTANCE AND INSTRUCTION, THE END USER WAS ABLE TO EVENTUALLY START THE DRIVER AND THE UNIT PRESSURIZED, BUT REPORTS, 5CMH20 LIGHT WAS ON AND THE DRIVER "SOUNDED FUNNY". CUSTOMER REQUESTED A REPLACEMENT UNIT. CAREFUSION AUTHORIZED A REPLACEMENT. PER ADDITIONAL INFORMATION RECEIVED ON JULY 18, 2013, THE CUSTOMER REPORTED, "[SHE] CODED AND DIED BEFORE THE SECOND OSCILLATOR FROM CAREFUSION ARRIVED. BUT, WE GOT ONE IN FROM ANOTHER RENTAL COMPANY THAT DIDN'T HAVE A BLENDER ON IT & WOULDN'T CALIBRATE EITHER. ONCE CAREFUSION DROPPED OFF THE SECOND ONE, THEY TOOK OUR OSCILLATOR. [SHE] HAD BEEN OFF OSCILLATOR FOR 6 1/2HRS BEFORE I COULD GET ONE ON HER & SHE WAS 7.0 PH BY THEN; GOT HER ON AT 930/945. THE PATIENT EXPIRED AT 3AM." ADDITIONAL INFORMATION SURROUNDING THE REPORTED EVENT HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67303 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death