BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3881790 · Received May 27, 2014

    Report

    Report Number
    1824206-2014-01636
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT EXPLAINED TO THE ACCOUNT HOW TO SET THE BED EXIT ALARM AND THE ACCOUNT IS NOW ABLE TO SET THE BED EXIT AND THE BED IS FUNCTIONING AS DESIGNED, USER ERROR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. NO REPAIR NEEDED THE BED FUNCTIONS AS DESIGNED. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED. .

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BED EXIT WOULD NOT SET. THE BED WAS LOCATED IN THE BED STOP AT THE FACILITY. THERE WAS NO PT/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
    310907 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1