BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 1830262 · Received September 2, 2010

    Report

    Report Number
    1831750-2010-01982
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 5, 2010
    Manufacturer
    STRYKER CORP. MEDICAL DIVISION
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER FACILITY MEDWATCH REPORT THAT IT APPEARS A BOLT IS COMING LOOSE WHICH COULD POSSIBLY CAUSE THE BRAKES NOT TO FUNCTION PROPERLY. ADDITIONALLY, IT WAS REPORTED THAT SOME UNITS HAVE HAD BOLTS LOOSEN ON THE LIFT HOUSING MOTOR. NO ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED A/C POWERED HOSPITAL BED FNL STRYKER CORP. MEDICAL DIVISION 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1