BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE ASSIST

    MDR report key: 3842899 · Received May 27, 2014

    Report

    Report Number
    MW5036373
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 23, 2014
    Manufacturer
    NURSE ASSIST
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT IS BELIEVED THE RN+ MONITOR DID NOT ALARM AND THE PATIENT SUSTAINED A FALL WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310311 NURSE ASSIST BED ALARM KMI NURSE ASSIST BPS-10RF

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR