BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE BED

    MDR report key: 3810313 · Received April 10, 2014

    Report

    Report Number
    1824206-2014-01139
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE BED EXIT TAPE SWITCH WAS THE CAUSE WHICH WAS MOST LIKELY CAUSE IS NORMAL WEAR AND TEAR. 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 BED EXIT TAPE SWITCH ASSEMBLY AND THE BED FUNCTIONED AS DESIGNED. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BED EXIT WAS NOT ALARMING. THE BED WAS LOCATED ON THE 3RD FLOOR 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
    216653 ADVANCE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1165

    Patients

    Seq Age Sex Outcome Treatment
    1