BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE FRAME

    MDR report key: 5041731 · Received August 31, 2015

    Report

    Report Number
    1824206-2015-00854
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    PMA / PMN Number
    PK962942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT SUGGESTED CHECKING THE PCM. PER THE HILL-ROM USER MANUAL, WARNING: THE BED EXIT SYSTEM IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE BED EXIT SYSTEM MUST BE USED IN CONJUNCTION WITH A SOUND RISK ASSESSMENT AND PROTOCOL. 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. . NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE BED EXIT ALARM DID NOT SOUND AT THE BED. THE BED WAS LOCATED IN THE MAINTENANCE SHOP AT THE ACCOUNT. THERE WAS NO PATIENT/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
    575048 TOTALCARE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM BATESVILLE P1900P006970

    Patients

    Seq Age Sex Outcome Treatment
    1