BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA BED

    MDR report key: 3893508 · Received February 14, 2014

    Report

    Report Number
    1824206-2014-00447
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE CAUSE WAS THE BED WAS NOT ZEROED BEFORE SETTING THE BED EXIT ALARM, USER ERROR. SEE SCANNED PAGE. THE TECHNICIAN ZEROED THE BED AND SET THE BED EXIT ALARM TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE ACCOUNT STATED THEY CANNOT SET THE BED EXIT. THE BED IS LOCATED IN THE MAINTENANCE ROOM AT THE FACILITY. 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
    99114 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1