BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 3850823 · Received March 21, 2014

    Report

    Report Number
    1824206-2014-00935
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE FOOT END BRAKE/STEER CASTER WAS NOT HOLDING WHEN IN BRAKE MODE DUE TO A BROKEN LEFT CAM PIVOT. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE LEFT CAM PIVOT 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 THE ACCOUNT STATING THE FRONT BRAKES WERE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT IN THE BED SHOP. 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
    169949 AFFINITY BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1