BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 3973240 · Received June 6, 2014

    Report

    Report Number
    9615739-2014-00229
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECH THOROUGHLY TESTED AND INSPECTED THE BED AND FOUND NO ISSUES. THE BED EXIT FUNCTIONED AS DESIGNED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2010-2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THAT THE BED EXIT WOULD NOT WORK. THE BED WAS LOCATED IN THE BASEMENT BED DOWN AREA AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331421 CAREASSIST BED A/C POWERED ADJUSTABLE HOSPTIAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1