BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE BED

    MDR report key: 3830121 · Received May 8, 2014

    Report

    Report Number
    1824206-2014-01431
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K962942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE LEFT FOOT SIDE RAIL WOULD NOT LATCH DUE TO SIDE RAIL BRACKET BENT FROM AN UNK SOURCE. THE MOST LIKELY CAUSE WOULD BE FORCE SUCH AS THE SIDE RAIL BEING HIT ON AN OBJECT DURING TRANSPORT. PER THE HILL-ROM SERVICE MANUAL THE TOTALCARE BED SYSTEM REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE SIDE RAIL FOR PROPER LATCHING. WHEN THE SIDE RAIL IS LATCHED, AN AUDIBLE CLICK SHOULD BE HEARD. GENTLY PULL ON SIDE RAIL TO MAKE SURE IT IS LATCHED PROPERLY. IF LATCHING IS DIFFICULT, MAKE SURE THAT THE LATCH IS CLEAN AND INSPECT FOR OBSTRUCTIONS. OF WEAR IS FOUND, REPLACE THE LATCH COMPONENTS. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECH REPLACED THE LEFT FOOT SIDE RAIL BRACKET TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE LEFT FOOT SIDE RAIL WOULD NOT LATCH IN THE UP POSITION. THE BED WAS LOCATED IN THE WAREHOUSE AT THE FACILITY. THERE WAS NO PT/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
    278253 TOTAL CARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1