BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA BED

    MDR report key: 3891674 · Received February 4, 2014

    Report

    Report Number
    1824206-2014-00304
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE UNIVERSAL TELEVISION BOARD WAS FAULTY. THE DEVICE REFERENCED IN THIS REPORT IS OVER 12 MONTHS OLD AND ACCORDING TO THE RECOMMENDED PREVENTIVE MAINTENANCE SCHEDULE AT LEAST ON E PM SHOULD BE PERFORMED EVERY 12 MONTHS. THEREFORE THE ACCEPTANCE CRITERIA, BASED ON THE DHR, WERE DETERMINED TO BE ACCEPTABLE AT THE TIME THE DEVICE WAS RELEASED GIVEN THE TIME WHICH HAS ELAPSED, THE ALLEGED FAILURE OF THE DEVICE WOULD NOT BE RELATED TO ANY ISSUE WHICH OCCURRED DURIN THE MANUFACTURING PROCESS. THE TECHNICIAN REPLACED THE UNIVERSAL TELEVISION BOARD JUNCTION BOX ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE PATIENT POSITION MODULE BED EXIT ALARM WILL ALARM AT THE BED BUT WILL NOT SEND A NURSE CALL. 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
    73790 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1