BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 2135056 · Received June 7, 2011

    Report

    Report Number
    2021710-2011-00039
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K051226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER FACILITY DID NOT ALLEGE THAT THE DEVICE MALFUNCTIONED IN ANY WAY. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH THE USER FACILITY REP. THE USER FACILITY PERFORMED AN INVESTIGATION OF THE INCIDENT AND DETERMINED THAT THE ROOT CAUSE OF THE INCIDENT WAS "USER ERROR", THUS NO EVALUATION OF THE DEVICE WAS PERFORMED. THE USER FACILITY REPORTED THAT THEY HAVE PROVIDED TRAINING ON THE PROPER PROCEDURES FOR FILLING/REFILLING THE HUMIDIFIER CHAMBER. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID NOT FIND ANY LIKE INCIDENCES, THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY. MEDWATCH REPORT RECEIVED BY CAREFUSION FROM THE FDA ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH VENTILATOR, NON-CONTINUOUS (RESPIRATOR) / BZD BZD CAREFUSION AIRLIFE NCPAP DRIVER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention