BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINAIR MEDSURG

    MDR report key: 2564166 · Received May 3, 2012

    Report

    Report Number
    1625774-2012-00031
    Event Type
    Death
    Date Received
    May 3, 2012
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BED PASSED QUALITY CONTROL (QC) CHECKS AND MET SPECIFICATIONS BEFORE AND AFTER PATIENT PLACEMENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2012, THE PATIENT ATTEMPTED TO EXIT THE BED AND FELL OUT THE LEFT SIDE OF THE BED. BOTH HEAD SIDE RAILS WERE IN THE UP POSITION. THE NURSE ASSISTED THE PATIENT BACK INTO THE BED. APPROXIMATELY 4 MINUTES LATER, THE PATIENT STOPPED BREATHING AND TURNED BLUE. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND CONTINUED FOR APPROXIMATELY 20 MINUTES. CPR WAS UNSUCCESSFUL, AND THE PATIENT WAS PRONOUNCED DEAD. THE FAMILY REFUSED TO HAVE AN AUTOPSY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR MEDSURG IOQ KCI USA, INC. KINAIR MEDSURG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death