BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARIMAXX II

    MDR report key: 1592975 · Received January 29, 2010

    Report

    Report Number
    1625774-2010-00007
    Event Type
    Malfunction
    Date Received
    January 29, 2010
    Date of Event
    December 30, 2009
    Report Date
    December 30, 2009
    Manufacturer
    KCI USA, INC.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BARIMAXX II POWER CORD WAS INSPECTED FOR DAMAGE ON (B)(4) 2009, PRIOR TO PLACEMENT AT THE HEALTHCARE FACILITY. SUBSEQUENT TO THE REPORTED EVENT, THE BARIMAXX II BED WAS RETURNED TO THE KCI SERVICE CENTER AND EVALUATED. EVALUATION OF THE POWER CORD CONFIRMED THAT THE NEUTRAL PRONG WAS MISSING AND REVEALED EVIDENCE THAT MELTING AND SCORCHING HAD OCCURRED AROUND THE AREA WHERE THE NEUTRAL PRONG HAD BEEN.

    Description of Event or Problem · 1

    ON (B)(6)2009, IT WAS REPORTED THAT THE POWER CORD PLUG ALLEGEDLY MALFUNCTIONED WHILE PLUGGED INTO THE WALL OUTLET AT THE HEALTHCARE FACILITY. THE BARIMAXX II BED WAS INITIALLY PLACED WITH THE ACCOUNT ON (B)(6) 2009. THERE WAS NO INJURY TO THE PATIENT OR HEALTHCARE FACILITY STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARIMAXX II FNL KCI USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1