BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINAIR MEDSURGE PULSE

    MDR report key: 1762699 · Received July 14, 2010

    Report

    Report Number
    MW5016740
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 14, 2010
    Manufacturer
    KCI
    Product Code
    IOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WAS ADMITTED WITH NECROTIZING PANCREATITIS. WAS PLACED ON A SPECIALTY BED DUE TO POOR NUTRITION. THE BED SIDERAIL WAS PUT UP TO ALLOW THE PT TO ASSIST HIMSELF IN ROLLING TO ONE SIDE. THE RAIL CAME DOWN AS THE PT GRABBED ONTO IT AND THE PT FELL FROM THE BED ONTO HIS FACE. HE SUSTAINED MULTIPLE FACIAL BRUISES AND A SPLENIC LACERATION. THE SIDERAIL WAS CHECKED BY MULTIPLE STAFF MEMBERS AFTERWARD AND THE BED WOULD APPEAR LOCKED AND THEN RELEASE WITHOUT WARNING. THE BED BELONGED TO KCI. IT WAS IMMEDIATELY TAKEN OUT OF SERVICE AND SENT BACK TO THE COMPANY. DATES OF USE: (B)(6) 2010 - (B)(6) 2010, 24 HOURS A DAY. DIAGNOSIS OR REASON FOR USE: POOR NUTRITIONAL INTAKE, POTENTIAL FOR SKIN BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR MEDSURGE PULSE KINAIR BED IOQ KCI KINAIR MEDSURGE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| O| R