BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 3851239 · Received March 25, 2014

    Report

    Report Number
    9615739-2014-00130
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 25, 2014
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE HEAD AND FOOT CASTER SUPPORTS BROKEN, THE CASTERS WERE WOBBLING AND NOT HOLDING FIRMLY WHEN BRAKE IS ENGAGED. ALSO THE STEER CASTER WAS NOT LOCKING WHEN STEER IS ENGAGED. SEE SCANNED PAGE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013 AND 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE HEAD AND FOOT CASTERS AND SUPPORTS 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 BRAKES AND STEERING WERE NOT WORKING. THE BED WAS LOCATED AT THE ACCOUNT GROUND FLOOR HALLWAY. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173954 CARE ASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1