BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 5010705 · Received August 18, 2015

    Report

    Report Number
    2031702-2015-00170
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 14, 2015
    Manufacturer
    CAREFUSION 203 INC
    Product Code
    CBK
    UDI-DI
    00845873000029
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER WAS UNABLE TO DUPLICATE CUSTOMER'S 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 NONCONFORMANCE WITH MEASURED SPO2. A VISUAL INSPECTION OF THE MAIN BOARD REVEALED THAT THE COMPONENTS U302, C342, AND C343 WERE BURNED. FURTHER INSPECTION REVEALED THAT JP4 PIN 4 WAS BURNED ON THE POWER FLEX CIRCUIT. THE MAIN BOARD AND POWER FLEX CIRCUIT WERE REPLACED TO CORRECT THE PROBLEMS THAT WERE FOUND DURING SERVICE. A REVIEW OF THE EVENT TRACE REVEALED SEVERAL BATTERY FAULT ALARM CONDITIONS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER HAD REPORTED THAT THE VENTILATOR WAS GOING INTO A BATTERY FAULT ALARM CONDITION WHICH THEY WERE UNABLE TO CLEAR. DURING SERVICE OF THE VENTILATOR, THE CAREFUSION SERVICE TECH FOUND THE VENTILATOR'S MAIN BOARD AND POWER FLEX CIRCUIT WERE DAMAGED WITH BURNED COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546543 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203 INC 19260-001 00845873000029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown