BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER BED CRITICAL CARE

    MDR report key: 2954102 · Received January 25, 2013

    Report

    Report Number
    MW5028889
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 25, 2013
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A TERRIBLE ODOR COMING FROM ONE OF THE NEW ICU BEDS. MAINTENANCE WAS CALLED. THE STAFF WAS IN THE ROOM TRYING TO LOCATE THE ODOR. IT WAS FOUND TO BE COMING FROM THE FOOT OF THE BED. THE PT WAS MOVED TO A DIFFERENT BED. THE BED WAS THEN EXAMINED AND FOUND TO HAVE A "HOT" AREA AT THE LOWER FOOT AREA. THE BED WAS REMOVED FROM THE ICU BY MAINTENANCE. CLINICAL ENGINEERING RECEIVED THE BED (B)(6) 2013. THEY PERFORMED INITIAL INSPECTION AND DELIVERED THE BED TO ICU. ON (B)(6) 2013, THE ON-CALL EMPLOYEE WAS CALLED TO ADDRESS THE BED IN QUESTION. THEY FOUND THE CHARGING CIRCUIT HAD OVER CHARGED THE BATTERIES CAUSING THEM TOO SWELL AND LEAK ACID INTO THE FRAME. ON (B)(6), A STRYKER FIELD SERVICE REP ARRIVED TO CHECK THE BED AND REPLACE THE BATTERIES. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE CHARGING CIRCUIT WAS CHARGING THE BATTERIES AT 31 VOLTS INSTEAD OF 24 VOLTS. THE BED HAS BEEN TAKEN OUT OF SERVICE UNTIL FURTHER NOTICE FROM STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35339 STRYKER BED CRITICAL CARE STRYKER HOSPITAL BED FNL STRYKER MEDICAL 2141 2141

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention