BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSACARE BED

    MDR report key: 2912917 · Received December 19, 2012

    Report

    Report Number
    1824206-2012-08332
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 29, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED THE ALLEGED INCIDENT AND THE NURSE STATED THAT ONE OF THE NURSES' ASSISTANTS HEARD THE PT CALLING OUT. THE NURSE ASSISTANT ENTERED THE ROOM AND FOUND THE PT ON THE FLOOR. NURSING ASSISTANT STATED THAT PT SAW THE BATHROOM LIGHT ON AND THOUGHT HER HUSBAND WAS IN THE BATHROOM AND THAT IS WHY SHE GOT UP FROM THE BED. THE ACCOUNT STATED THE BED ALARM WAS NOT ALARMING BECAUSE IT WAS NOT SET. THE TECHNICIAN INSPECTED THE BED AD FOUND NO ISSUE. THE TECHNICIAN CHECKED BED FUNCTIONS AND THE PT POSITION MODULE AND BED EXIT ALARM AND THEY FUNCTIONED AS DESIGNED. THE ACCOUNT STATED THE PT HAS A BROKEN LEFT WRIST FROM THE ALLEGED FALL AND A CAST WAS APPLIED ON THEIR LEFT WRIST FOR TREATMENT.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THERE WAS A PT IN THE BED WITH THE PT POSITION MODULE SET. THE PT WAS ABLE TO EXIT THE BED WITHOUT THE PT POSITION MODULE ALARMING. THE ACCOUNT WAS ASKED IF THERE WERE ANY INJURIES AND THE ACCOUNT WOULD NOT ANSWER THAT QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention