BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 5011754 · Received August 13, 2015

    Report

    Report Number
    1824206-2015-00820
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BED EXIT ALARM INOPERABLE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2012-2015. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE ACCOUNT REPLACED THE BED EXIT ALARM 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 A HILL-ROM TECHNICIAN STATING THE BED EXIT ALARM WAS INAUDIBLE. THE BED WAS LOCATED 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
    535557 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1