BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 3810292 · Received April 10, 2014

    Report

    Report Number
    1824206-2014-01136
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BRAKE CASTER NOT HOLDING DUE TO THE DETENT MECHANISM WORN OUT DUE TO AGE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2006 AND 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE DETENT MECHANISM TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING BRAKES WOULD NOT HOLD. THE BED WAS LOCATED AT THE ACCOUNT IN THE HCA WAREHOUSE. THERE WAS NO PT/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
    216258 AFFINITY BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1