BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3973794 · Received May 15, 2014

    Report

    Report Number
    1824206-2014-01496
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT THE SIDE RAIL WOULD NOT LATCH IN THE UP POSITION. THE TECHNICIAN BELIEVES THE MOST LIKELY CAUSE IS THAT THE BED HAD BEEN RAISED WITH THE SIDE RAIL UNDER AN OBJECT LIKE A RAILING OR WINDOW LEDGE. THE SIDE RAIL CENTER ARM HAD EXCESSIVE FORCE APPLIED TO IT. 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 SIDE RAIL CENTER ARM AND CENTER ARM COVER WERE REPLACED BY THE TECHNICIAN TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE SIDE RAIL IS DAMAGED AND NEEDS A TECHNICIAN FOR REPAIR. THE BED WAS LOCATED IN THE BASEMENT AT THE FACILITY. 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
    289944 VERSACARE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1