BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3810216 · Received February 5, 2014

    Report

    Report Number
    1824206-2014-00320
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE FOOT RIGHT SIDE RAIL CENTER ARM ASSEMBLY WAS CONTAMINATED. THE DEVICE REFERENCED IN THIS REPORT IS OVER 12 MONTHS OLD AND ACCORDING TO THE RECOMMENDED PREVENTIVE MAINTENANCE SCHEDULE AT LEAST ONE PM SHOULD BE PERFORMED EVERY 12 MONTHS. THEREFORE, THE ACCEPTANCE CRITERIA, BASED ON THE DHR WERE DETERMINED TO BE ACCEPTABLE AT THE TIME THE DEVICE WAS RELEASED. GIVEN THE TIME WHICH HAS ELAPSED, THE ALLEGED FAILURE OF THE DEVICE WOULD NOT BE RELATED TO ANY ISSUE WHICH OCCURRED DURING THE MANUFACTURING PROCESS. THE TECH REMOVED AND CLEANED AND LUBRICATED THE FOOT RIGHT SIDE RAIL CENTER ARM ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECH REPORTED THE FOOT RIGHT SIDE RAIL IS NOT LATCHING. THE TECH STATED THE BED WAS NOT IN USE. 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
    75762 VERSACARE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1