BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEL

    MDR report key: 4922784 · Received July 17, 2015

    Report

    Report Number
    2031702-2015-00139
    Event Type
    Injury
    Date Received
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS AND PASSED THE INITIAL ALARM VOLUME TEST. DURING THE INITIAL FINAL TEST, THE VENTILATOR HAD A NON-CONFORMANCE WITH MEASURED VTE AT THE PTV FLOW AND THE VOLUME PERFORMANCE TEST 3. IT IS RECOMMENDED THAT THE PRESSURE MODULE BE REPLACED TO CORRECT THE PROBLEM THAT WAS IDENTIFIED DURING TESTING. A VISUAL INSPECTION FOUND THE POWER FLEX CIRCUIT WAS DAMAGED WHERE PINS 4 AND 5 OF JP4 WERE BURNED. IT IS ALSO RECOMMENDED THAT THE POWER FLEX CIRCUIT BE REPLACED. REVIEW OF THE EVENT TRACE REVEALED SEVERAL ¿BLOWER DEMAND EXCEEDED ALARM¿ CONDITIONS. THE EVENT TRACE INDICATES THAT THE "BLOWER DEMAND EXCEEDED ALARM" CONDITIONS WERE PRECEDED BY ALARM CONDITIONS THAT INDICATE THE PRESENCE OF A SIGNIFICANT PATIENT CIRCUIT LEAK. THESE PRECEDING ALARM CONDITIONS INCLUDE "LOW VE ALARM", "LOW PPEAK ALARM", "LOW PEEP ALARM", AND "HIGH BREATH RATE ALARM" WHICH REPEATEDLY TRIGGER THEN RECOVER ALONG WITH THE "BLOWER DEMAND EXCEEDED ALARM" CONDITION. THE PRESENCE OF A PATIENT CIRCUIT LEAK IN EXCESS OF THE 30LPM LEAK COMPENSATION CAPABILITIES OF THE PTV VENTILATOR CAN RESULT IN CONTINUOUS PEAK BLOWER OPERATION WHILE THE VENTILATOR ATTEMPTS TO MEET THE BREATH REQUIREMENT SETTINGS OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSPORT OF A PATIENT, THE TRANSPORT MONITOR RESPIRATORY RATE WAS ONLY READING 12-13 WHEN THE VENTILATOR WAS SET TO A RATE OF 26. THE PATIENT'S ETCO2 WAS BETWEEN 58-62 (CORRELATED WITH A RECENT ABG AND RELATIVELY APPROPRIATE FOR HIS PATHOLOGIES) AND SPO2 REMAINED ABOVE 94-95%. WITHOUT PROVOCATION, THE VENTILATOR BEGAN VENTILATING THE PATIENT AT THE SET RATE OF 26 AND WAS CONFIRMED WITH CHEST RISE. NO PATIENT HARM REPORTED. THE PATIENT'S ETCO2 IMPROVED TO 47-50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466386 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening