BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC BED

    MDR report key: 3973086 · Received June 5, 2014

    Report

    Report Number
    1824206-2014-01718
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE SIDERAIL NOT LATCHING DUE TO THE COVER BENDING. THIS WAS MOST LIKELY DUE TO IT BEING FORCED OPEN OR CLOSED AT SOME POINT, BENDING THE COVER TO THE POINT THAT THE LATCH PHYSICALLY CAUGHT THE COVER. 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 PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN BENT BACK THE SIDERAIL METAL COVER TO THE CORRECT SHAPE AND REPAINTED 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 A HILL-ROM TECHNICIAN STATING THE LEFT FOOT SIDERAIL IS NOT LATCHING. THE BED WAS LOCATED AT A HILL-ROM SERVICE CTR NOT IN USE. 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
    328549 TOTALCARE BARIATRIC BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1