BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE BED

    MDR report key: 3893380 · Received February 11, 2014

    Report

    Report Number
    1824206-2014-00377
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, THE TECHNICIAN FOUND THAT THE BRAKE CASTERS ON THE DEVICE WERE WORN OUT DUE TO AGE AND REGULAR WEAR AND TEAR ASSOCIATED WITH DEVICES THIS AGE. THE BRAKE CASTERS HAVE BEEN IN SERVICE SINCE 1992 AND THE BRAKES WERE LAST REPLACED IN OCTOBER 2006. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE BRAKE CASTER AND BRAKE STEER CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE BRAKES ARE NOT HOLDING. THE BED IS LOCATED IN THE FACILITIES WAREHOUSE. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91272 ADVANCE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 1130

    Patients

    Seq Age Sex Outcome Treatment
    1