BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 5020866 · Received August 21, 2015

    Report

    Report Number
    1824206-2015-00833
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN HAS NOT INVESTIGATED THE BED. PER THE HILL-ROM USER MANUAL, WARNING: THE BED EXIT ALARM SYSTEM IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE BED EXIT ALARM SYSTEM MUST BE USED IN CONJUNCTION WITH A SOUND RISK ASSESSMENT AND PROTOCOL. PER THE HILL-ROM USER MANUAL, IF THE BED EXIT ALARM DOES NOT ARM AND ALL THREE MODE INDICATORS ARE FLASHING, REMOVE THE PATIENT AND ZERO THE BED EXIT SYSTEM. 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 THE ACCOUNT STATING THE BED ALARM HAD NO SOUND. THE BED WAS LOCATED 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
    555924 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNK HILL-ROM BATESVILLE 3200

    Patients

    Seq Age Sex Outcome Treatment
    1