BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 3952226 · Received May 13, 2014

    Report

    Report Number
    1824206-2014-01479
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE DETENT ASSEMBLY WAS BROKEN. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2009-2011 AND 2013 TO 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE BRAKE DETENT ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED IN THE LABOR AND DELIVERY DEPARTMENT. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285599 AFFINITY BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1