BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE FRAME

    MDR report key: 5019332 · Received August 20, 2015

    Report

    Report Number
    1824206-2015-00825
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 28, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE COMMUNICATION CABLE INOPERABLE. 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 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 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 NURSE CALL 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
    552071 VERSACARE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNK HILL-ROM BATESVILLE 3200

    Patients

    Seq Age Sex Outcome Treatment
    1