BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA FRAME

    MDR report key: 5017795 · Received August 20, 2015

    Report

    Report Number
    1824206-2015-00822
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT SUGGESTED TO CHECK THE SIDE RAIL SWITCHES. PER THE HILL-ROM SERVICE MANUAL THE ADVANTA BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. RUN THE HEAD SECTION TO THE FULL UPPER AND LOWER LIMITS TO ENSURE PROPER FUNCTION OF THE LIMIT SWITCHES. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THREE ATTEMPTS HAVE BEEN MADE REGARDING A RESOLUTION TO THIS CONTACT LINE, WITH NO RESPONSE. 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 HEAD SECTION WOULD SELF-RUN WHEN THE BED IS PLUGGED IN. THE BED WAS LOCATED IN A REGULAR PATIENT CARE ROOM 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
    550890 ADVANTA FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNK HILL-ROM BATESVILLE 1600

    Patients

    Seq Age Sex Outcome Treatment
    1