BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2 BED

    MDR report key: 3925093 · Received June 17, 2014

    Report

    Report Number
    3006697241-2014-00518
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    HILL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND A DEFECTIVE SIDECOM POWER CONTROL BOARD. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013 AND 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE SIDE COM POWER CONTROL BOARD TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. (B)(4)

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE NURSE CALL FUNCTION IS NOT WORKING. THE BED WAS LOCATED AT THE ACCOUNT IN ENGINEERING. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355776 ADVANTA 2 BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM DE MEXICO S DE RL DE CV 1190

    Patients

    Seq Age Sex Outcome Treatment
    1