BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINET BED EXIT ALARM

    MDR report key: 5888365 · Received August 16, 2016

    Report

    Report Number
    MW5064187
    Event Type
    Other
    Date Received
    August 16, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 16, 2016
    Manufacturer
    LINET AMERICAN
    Product Code
    KMI
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DETERMINED TO BE AT RISK FOR FALLING. AS A PREVENTATIVE MEASURE, THE LINER INTEGRATED BED ALARM WAS ENGAGED SO THAT STAFF WOULD BE ALERTED IF THE PT EXITED THE BED. THE STAFF APPARENTLY FORGOT TO RE-ENGAGE THE ALARM DURING THE NIGHT. STAFF WERE UNAWARE THAT THE PT EXITED THE BED. THE PT FELL AND BROKE HIS RIB. THE INDICATOR LIGHT FOR THE BED ALARM IS VERY SMALL AND STAFF NEED TO GO TO THE HEAD OF THE BED TO SEE IF IT IS ON. WE WOULD LIFE FOR THIS LIGHT TO BE MORE VISIBLE. MORE IMPORTANTLY, WE CHALLENGE THE MFR TO DESIGN SAFETY MECHANISMS THAT ADDRESS HUMAN FAILURES. NAMELY, WE WOULD LIKE TO HAVE A BED ALARM THAT AUTOMATICALLY RE-ENGAGES WHEN WEIGHT IS RE-ESTABLISHED ON THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532684 LINET BED EXIT ALARM BED EXIT ALARM KMI LINET AMERICAN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other