BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE FRAME

    MDR report key: 5055998 · Received September 4, 2015

    Report

    Report Number
    1824206-2015-00866
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 14, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE SIDE COMMUNICATION CABLE WAS THE ISSUE. 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 ZERO THE BED EXIT SYSTEM. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE SIDE COMMUNICATION CABLE 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 WOULD ALARM, BUT WOULD NOT SEND A CALL TO THE NURSES' STATION. THE BED WAS LOCATED IN ROOM 8404 AT THE FACILITY. 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
    586801 VERSACARE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM BATESVILLE P3200K000425

    Patients

    Seq Age Sex Outcome Treatment
    1