BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY THREE BIRTHING BED

    MDR report key: 3841127 · Received February 26, 2014

    Report

    Report Number
    1824206-2014-00651
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    PMA / PMN Number
    K915779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE RIGHT SIDE RAIL DAMPENER WAS LOCKED IN PLACE AND NOT MOVING WHEN THE SIDE RAIL WAS LIFTED SO THE SIDE RAIL COULD NOT LIFT TO THE LATCH POSITION. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE RIGHT SIDE RAIL DAMPENER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE RIGHT SIDE RAIL WOULD NOT LATCH. THE BED WAS LOCATED IN LABOR AND DELIVERY 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
    117717 AFFINITY THREE BIRTHING BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1