BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINAIR

    MDR report key: 1620926 · Received February 5, 2010

    Report

    Report Number
    1625774-2010-00012
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 8, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1625774-10/28/2009-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURES ON (B)(6)2009, PRIOR TO DELIVERY TO THE ACCOUNT, AND MET SPECIFICATIONS. SUBSEQUENT TO THE REPORTED EVENT, THE KINAIR MEDSURG BED WAS RETURNED TO THE KCI SERVICE CENTER AND EVALUATED. EVALUATION OF THE POWER CORD CONFIRMED THAT THE LINE PRONG WAS MISSING AND REVEALED EVIDENCE THAT MELTING AND SCORCHING HAD OCCURRED.

    Description of Event or Problem · 1

    ON 01/08/10, IT WAS REPORTED THAT THE POWER CORD PLUG ALLEGEDLY MALFUNCTIONED WHILE PLUGGED INTO THE WALL OUTLET AT THE HEALTHCARE FACILITY. THE KINAIR MEDSURG 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 KINAIR IOQ KCI USA, INC. MEDSURG NA

    Patients

    Seq Age Sex Outcome Treatment
    1