BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTURY BED

    MDR report key: 2120171 · Received June 2, 2011

    Report

    Report Number
    1824206-2011-03046
    Event Type
    Death
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 10, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTENDING NURSE INDICATED NO ONE AT THE ACCOUNT WITNESSED THE ALLEGED INCIDENT. SHE SAID WHEN SHE ENTERED THE ROOM THE PATIENT WAS FOUND ON THE FLOOR NEXT TO THE BED AND SPECULATED THAT THE PATIENT MAY HAVE BEEN REACHING FOR A PENDANT OR PHONE BUT NO ONE IS SURE. THE NURSE STATED THAT SHE TESTED THE BEDS BRAKES AT THE TIME OF THE INCIDENT WHEN SHE ENTERED THE ROOM AND THE BED CASTERS ROLLED WITH THE BRAKES SET. THE FIELD TECHNICIAN INVESTIGATED AND FOUND THE BED WAS GENERALLY IN POOR CONDITION. THE 25 YEAR OLD BED WAS RUSTED AND APPEARED TO STILL HAVE THE ORIGINAL CASTERS WHICH WERE CRACKED AND DETERIORATED. THE TECHNICIAN TESTED THE BRAKES MULTIPLE TIMES AND FOUND THE BRAKES WOULD SET AND HOLD ON THE BED. THE TECHNICIAN ASKED THE ACCOUNTS BIOMED ABOUT THEIR PREVENTIVE MAINTENANCE PROCEDURE. THE BIOMED DID NOT HAVE A SERVICE MANUAL BUT STATED THAT PREVENTIVE MAINTENANCE IS PERFORMED ON THEIR BEDS EACH YEAR AND WAS LAST PERFORMED ON THIS BED (B)(6) 2010. THE ACCOUNT HAS PLACED THE BED IN STORAGE AT THIS TIME. THE ACCOUNT HAS NOT RETURNED MESSAGES LEFT REGARDING THE SIDERAIL POSITIONS AND CAUSE OF DEATH.

    Description of Event or Problem · 1

    THE ACCOUNTS RISK MANAGER STATED ON (B)(6) 2011 A PATIENT RECEIVED A SERIOUS HEAD INJURY, MODERATE SIZE HEMATOMA TO THE TOP AND BACK OF THE HEAD, DUE TO THE BRAKES NOT HOLDING ON THE BED. SHE STATED THE PATIENT EXPIRED A FEW HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 835

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death