BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3812505 · Received April 17, 2014

    Report

    Report Number
    1824206-2014-01221
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 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 HILL-ROM TECHNICIAN THOROUGHLY TESTED AND INSPECTED THE BED AND FOUND NO ISSUES. THE BED ALARMS FUNCTIONED AS DESIGNED. PER THE HILL-ROM USER MANUAL, WARNING: THE BED EXIT ALARM SYSTEM IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE BED EXIT ALARM SYSTEM MUST BE USED IN CONJUNCTION WITH A SOUND RISK ASSESSMENT AND PROTOCOL. PER THE HILL-ROM USER MANUAL, IF THE BED EXIT ALARM DOES NOT ARM AND ALL THREE MODE INDICATORS ARE FLASHING, REMOVE THE PATIENT AND XERO THE BED EXIT SYSTEM. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. 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 BED EXIT WAS NOT ALARMING. THE BED WAS LOCATED AT THE ACCOUNT IN THE HCA WAREHOUSE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236261 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1