BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE RENTAL BED

    MDR report key: 3931550 · Received April 14, 2014

    Report

    Report Number
    1824206-2014-01179
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 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

    THE TECHNICIAN FOUND THE HEAD LEFT BRAKE CASTER WOULD NOT LOCK WHEN SET. 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. THE TECHNICIAN CALIBRATED THE BRAKE CASTERS 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 BRAKES WERE NOT HOLDING. THE BED WAS LOCATED IN A HILL-ROM SERVICE CENTER AND NOT IN USE. THERE WAS NO PT/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
    226798 VERSACARE RENTAL BED AC POWERED ADJUSTALBE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1