BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACARE BED

    MDR report key: 1790185 · Received August 3, 2010

    Report

    Report Number
    1824206-2010-09126
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    May 11, 2010
    Report Date
    July 9, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT STATED THAT THE INCIDENT WAS A RESULT OF NURSING USER ERROR. THE NURSE DID NOT SET THE BED EXIT ALARM AND THE PATIENT CLIMBED OUT OF THE BED AND FELL. THE ACCOUNTS MAINTENANCE CHECKED THE BED AND FOUND THE BED TO BE OPERATING PROPERLY AND IT WAS PLACED BACK INTO SERVICE. THE ACCOUNT WOULD NOT RELEASE ANY PATIENT INFORMATION.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED, THERE WAS A PATIENT THAT HAD FALLEN AND RECEIVE BROKEN BONES DUE TO THE FALL. THE ACCOUNT ALLEGED THAT THE PATIENT POSITIONING MONITOR (PPM) WAS SET AT AN EARLIER TIME DURING THE PATIENT STAY, BUT IT WAS DETERMINED THAT THE PPM WAS NOT SET AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED AC POWERED HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK