BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSACARE BED VERSACARE FRAME

    MDR report key: 1613093 · Received February 4, 2010

    Report

    Report Number
    1824206-2010-01783
    Event Type
    Other
    Date Received
    February 4, 2010
    Date of Event
    October 29, 2007
    Report Date
    October 30, 2007
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE RISK MGR, PT WAS FOUND ON FLOOR NEAR BED AT NOONTIME. ACCOUNT STATED, PT WAS ABLE TO LET SIDERAIL DOWN. ACCOUNT STATED THAT BED EXIT ALARM DIDN'T ALARM. PT WAS FOUND LATER THE SAME DAY WITH LEGS DANGLING OVER THE EDGE OF BED. THE PT WAS NOT ABLE TO FALL, SIDE RAILS STILL UP. THE ONLY REPORT OF INJURIES BY RISK MGR AT THE TIME OF THIS REPORT, WAS THAT THEY WERE MINOR. NO OTHER DETAILS WERE GIVEN AT THIS TIME. TECH CHECKED ALL BED FUNCTIONS, NO PROBLEMS FOUND. PLUGGED BED INTO ANOTHER ROOM WITH NURSE CALL SYSTEM. COULDN'T DUPLICATE ANY PROBLEMS. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED PT FELL OUT OF BED AND WAS FOUND ON THE FLOOR. THE RISK MGR ALLEGED THE BED EXIT DID NOT SOUND. ACCOUNT STATED THAT THE RISK MGR DID NOT RELEASE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED VERSACARE FRAME A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM RITTER P3200A000035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other