BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA BED

    MDR report key: 3881498 · Received February 19, 2014

    Report

    Report Number
    1824206-2014-00521
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE LEFT HEAD SIDERAIL WAS BENT. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2006-2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REMOVED ALL THE PARTS FROM THE LEFT HEAD SIDERAIL AND INSTALLED A NEW RAIL FRAME TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE LEFT HEAD SIDERAIL WOULD NOT GO UP OR LATCH. THE BED IS LOCATED IN THE BED SHOP. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104218 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1604

    Patients

    Seq Age Sex Outcome Treatment
    1