BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTURY CCU BED

    MDR report key: 1053571 · Received May 28, 2008

    Report

    Report Number
    1824206-2008-02585
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    May 4, 2008
    Report Date
    May 16, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICIAN REPORTED THAT THERE WAS A NON HILL ROM MATTRESS ON THE BED. THE MATTRESS WAS 7 INCHES THICK AND THE IDENTIFICATION TAGS WERE MISSING. THE MATTRESS THICKNESS PLUS THE THICKNESS OF THE OVERLAY LEFT 4-5 INCHES OF SIDERAIL CONTAINMENT FROM THE PATIENT. HE FOUND NO PROBLEMS WITH THE BED AND IT OPERATED AS DESIGNED. THE HOSPITAL WOULD NOT RELEASE ANY PATIENT INFORMATION.

    Description of Event or Problem · 1

    SAFETY OFFICER, SUBMITTED AN E-MAIL THAT STATED A PATIENT ROLLED OVER THE BED SIDERAILS. GREG STATED THAT ALL OF THE SIDERAILS WERE IN THE UP POSITION WHEN THE EVENT OCCURRED. HE REPORTED THAT THERE WAS AN OVERLAY ON THE MATTRESS WHEN THE EVENT OCCURRED. THE HILL-ROM TECHNICIAN, WHO INVESTIGATED THE EVENT, REPORTED THAT UNIT MANAGER STATED THAT THE PATIENT ROLLED OVER THE SIDERAILS AND FELL ONTO THE FLOOR. THE SIDERAILS WERE IN THE UP POSITION WHEN THIS EVENT OCCURRED. SUSAN STATED THE BED WAS IN THE LOWEST POSITION AND THE HEAD SECTION WAS ELEVATED 20 TO 30 DEGREES. THERE WAS AN HILL-ROM ACUCAIR OVERLAY INSTALLED ON THE MATTRESS AND THE ACUCAIR WAS IN MAX INFLATE AT THE TIME OF THE EVENT. UNIT MANAGER REPORTED THAT THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY CCU BED AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 894 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK