BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC BED

    MDR report key: 4002004 · Received July 3, 2014

    Report

    Report Number
    1824206-2014-01903
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    IOQ
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE LEFT SIDE RAIL LATCH WAS CONTAMINATED WITH A STICKY SUBSTANCE FROM DRIED FLUIDS THAT HAD PENETRATED THE SIDE RAILS CENTER ARM AND LATCHING MECHANISM ASSEMBLY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2012 THROUGH 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN CLEARED THE LEFT SIDE RAIL LATCHING MECHANISM TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THAT THE LEFT FOOT SIDE RAIL IS NOT LATCHING. THE BED WAS LOCATED ON THE 4TH FLOOR AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389060 TOTALCARE BARIATRIC BED AC POWERED ADJSUTABLE HOSPITAL BED IOQ HILL-ROM INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1