BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTALCARE BARIATRIC BED

    MDR report key: 4992204 · Received August 7, 2015

    Report

    Report Number
    1824206-2015-00797
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE PATIENT WAS TURNING HIMSELF IN THE BED. THE PATIENT LEANED AGAINST THE SIDERAIL AND IT GAVE AWAY. THE PATIENT FELL FROM THE BED. THE PATIENT WAS TAKEN FOR X-RAYS WHICH SHOWED HIS HIP WAS BROKEN. NO SURGERY WAS NEEDED AND IS BEING TREATED BY THE STAFF. 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 HILL-ROM TECHNICIAN FOUND THE BED FUNCTIONING AS DESIGNED. THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE REPAIR, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING ALLEGED THAT A PATIENT FELL OFF THE BED. THE PATIENT FELL AND BROKE HIS HIP. THE BED WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520988 TOTALCARE BARIATRIC BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other