BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 3941056 · Received April 24, 2014

    Report

    Report Number
    1824206-2014-01291
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K962942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE SIDERAIL NOT LATCHING DUE TO FLUIDS/BLOOD GETTING IN THE LATCH HARDENING AND PREVENTING IT FROM OPERATING NORMAL. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2009-2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE LATCH AND SPRING TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM REC'D A REPORT FROM THE ACCOUNT STATING THE RIGHT INTERMEDIATE SIDE RAIL IS NOT LATCHING IN THE UPRIGHT POSITION. THE BED WAS LOCATED AT THE ACCOUNT IN INTENSIVE CARE UNIT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248325 TOTALCARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1