BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION

    MDR report key: 6135980 · Received November 30, 2016

    Report

    Report Number
    2021710-2016-04946
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 30, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    BZD
    PMA / PMN Number
    K031745
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: FACTORY SERVICE RECEIVED THE SUSPECT SIPAP DEVICE AND EVALUATED THE UNIT. AN EVALUATION OF THE DEVICE DID NOT DUPLICATE THE REPORTED ISSUE. THE VALVE/SENSOR PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REPLACED AS A PRECAUTIONARY MEASURE AND THE UNIT WAS RETURNED TO THE CUSTOMER. IN THE EVENT THAT ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERROR CODE E33 OCCURRED WHEN THE DEVICE HAD JUST BEEN PLACED ON A PATIENT. THERE WAS NO PATIENT COMPROMISE ASSOCIATED WITH THE REPORTED ISSUE. THE PATIENT WAS SWITCHED TO ANOTHER SIPAP UNIT. THE CUSTOMER PUT THE DEVICE INTO DIAGNOSTIC MODE AND SAW THE E33 CODE AND CLEARED IT. THE CUSTOMER PERFORMED THE PRESSURE CALIBRATION AND THE ZERO PASSED. WHEN THE CUSTOMER SET THE PRESSURE TO 10 AND HIT THE PRESSURE KEY, INITIALLY THE UNIT SHOWED A "GREEN CHECK MARK" AS IF IT HAD PASSED, BUT THEN QUICKLY CHANGED TO A "RED X" AND THE E33 ERROR CODE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786076 INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION VENTILATOR, NON-CONTINUOUS BZD CAREFUSION, INC SIPAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention