BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL CARE FRAME

    MDR report key: 5021908 · Received August 21, 2015

    Report

    Report Number
    1824206-2015-00835
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT PURCHASED THE BED FROM ((B)(6)). THE REPORTED INJURIES ARE SERIOUS IN NATURE PER FDA DEFINITION. HOWEVER, HILL-ROM WAS UNABLE TO DETERMINE IF A MALFUNCTION TOOK PLACE. THE CUSTOMER INDICATED THEY WILL ASSES/SERVICE THE BED SEPARATELY. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE MATTRESS WAS NOT INFLATING PROPERLY AND THE PATIENT DEVELOPED A STAGE 4 WOUND ON HIS BACKSIDE. THE PATIENTS WOUND WAS TREATED WITH A WOUND VAC. THE BED WAS LOCATED IN THE PATIENTS HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554408 TOTAL CARE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNK HILL-ROM BATESVILLE P1900D003373

    Patients

    Seq Age Sex Outcome Treatment
    1 Other