BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE FRAME

    MDR report key: 6165914 · Received December 12, 2016

    Report

    Report Number
    1824206-2016-00525
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    October 10, 2016
    Report Date
    November 25, 2016
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE EXTERNAL ALARM NEEDED TO BE REPLACED. PER THE HILL-ROM SERVICE MANUAL, PERFORM ANNUAL PREVENTIVE MAINTENANCE PROCEDURES TO MAKE SURE ALL VERSACARE® BED COMPONENTS ARE FUNCTIONING AS ORIGINALLY DESIGNED. BRAKE CASTERS SHOULD BE CHECKED FOR CUTS, WEAR AND QUALITY OF TREAD, ETC. AND REPLACED WHEN NECESSARY. EXAMINE THE BRAKES TO SEE WHETHER THE BED MOVES WHEN THE BRAKE ARE SET. REPLACE AS NECESSARY. 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 ACCOUNT REPLACED THE EXTERNAL 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 THE ACCOUNT STATING THE BRAKE NOT SET ALARM 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818662 VERSACARE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM BATESVILLE P3201K000374

    Patients

    Seq Age Sex Outcome Treatment
    1