BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA BED

    MDR report key: 3850833 · Received March 21, 2014

    Report

    Report Number
    1824206-2014-00943
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE HEAD SIDERAILS WERE RUSTY. 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 HILL-ROM TECHNICIAN REPLACED THE HEAD LEFT AND RIGHT SIDERAILS 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 HEAD SIDERAILS WOULD NOT LATCH PROPERLY. THE BED WAS LOCATED IN ENGINEERING AT THE ACCOUNT. 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
    170357 CENTRA BED A/C POWERED ADJUTABLE HOSPITAL BED FNL HILL-ROM, INC. 1050

    Patients

    Seq Age Sex Outcome Treatment
    1