BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 5093543 · Received September 22, 2015

    Report

    Report Number
    1824206-2015-00905
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 31, 2015
    Report Date
    August 31, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE NURSE CALL CABLE PINS WERE DAMAGED. PER THE HILL-ROM USER MANUAL, WARNING: A COMMUNICATION CABLE MUST BE USED FOR BEDS THAT HAVE NURSE CALL. FAILURE TO DO SO COULD CAUSE PATIENT INJURY. FOR BEDS THAT HAVE NURSE CALL SYSTEMS, A COMMUNICATION CABLE MUST BE CONNECTED BETWEEN THE BED AND FACILITY COMMUNICATION SYSTEM. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2014 AND 2015. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE 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 NURSE CALL WAS NOT WORKING. 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
    625355 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM BATESVILLE 3200

    Patients

    Seq Age Sex Outcome Treatment
    1