BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 2760180 · Received September 20, 2012

    Report

    Report Number
    1824206-2012-05697
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 29, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED THE INCIDENT AND THE NURSE STATED THAT THERE WAS NO WITNESS TO THE EVENT. THE PATIENT CLAIMED THEY FELL OUT OF THE BED DURING THE NIGHT WHILE ASLEEP WHEN THE MORNING NURSE CAME IN. THE PATIENT WAS NOT INJURED AND CLIMBED BACK INTO THE BED AND WENT BACK TO SLEEP. THE NURSE COULD NOT RECALL IF THE SIDERAILS WERE RAISED OR LOWERED THE NEXT MORNING. THE TECHNICIAN FOUND NO ISSUE WITH THE SIDE RAILS AND ALL SIDE RAILS FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    THE NURSE ALLEGED THAT THE PATIENT FELL OUT OF THE BED DURING THE NIGHT DUE TO THE LEFT INTERMEDIATE SIDE RAIL UNLATCHING WHEN THE PATIENT ROLLED ONTO IT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other