BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 3240868 · Received July 17, 2013

    Report

    Report Number
    9615739-2013-00205
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED AND FOUND THAT THE SCALE BED EXIT POD WAS NOT FUNCTIONING. THE TECHNICIAN REPLACED THE SCALE POD MEMBRANES ON BOTH SIDE RAILS TO RESOLVE THE ISSUE. THE ACCOUNT STATED THERE WAS NO INJURY FROM THE FALL. THE ACCOUNT DID A NURSE ASSESSMENT TO FOLLOW THEIR SAFETY PROCEDURE FOR FALLS.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THERE WAS A PT FALL AND THE PT POSITION MODULE WAS SET AND DID NOT ALARM. THE ACCOUNT DID NOT HAVE INFO ON THE EXTENT OF THE INJURY OR IF THERE WAS ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332793 CAREASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other