BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3821307 · Received April 28, 2014

    Report

    Report Number
    1824206-2014-01327
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BED EXIT REQUIRED RESET. PER THE HILL-ROM USER MANUAL: ZEROING THE SCALE: THE BED MUST BE ZEROED BEFORE THE PATIENT IS PUT ON THE BED. BE SURE TO PUT ALL LINENS, PILLOWS, AND EQUIPMENT ON THE BED BEFORE ZEROING. SEE SCANNED PAGE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2012 AND 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN ZEROED THE BED EXIT ALARM USING THE PATIENT CAREGIVER KEYPAD 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 BED EXIT ALARM WOULD NOT ENGAGE (SET). THE BED WAS LOCATED AT THE ACCOUNT ON THE 3RD FLOOR. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254422 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1