BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T MATE

    MDR report key: 4371856 · Received December 18, 2014

    Report

    Report Number
    4371856
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 10, 2014
    Manufacturer
    210 INNOVATION, LLC
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    ITEM FAILED TO ALARM WHEN PATIENT WAS HELPED OUT OF CHAIR BY A STAFF MEMBER. ALARM WAS ATTACHED PROPERLY TO PATIENT; THE MAGNET WAS PULLED AWAY FROM THE DEVICE WHEN PATIENT STOOD, HOWEVER DEVICE DID NOT ALARM. THE LOW BATTERY LIGHT DID NOT COME ON TO INDICATE THE BATTERY WAS NOT WORKING. THE DEVICE HAD FALLEN TO THE FLOOR EARLIER IN THE DAY; HOWEVER, APPEARED TO BE WORKING UPON INSPECTION. AS THE DEVICE IS UNABLE TO BE CLIPPED TO THE BACK OF A MEDICHAIR, IT IS OFTEN WEDGED BETWEEN THE ARM AND THE BACK AND CAN EASILY FALL TO THE FLOOR.THESE DEVICES ARE FREQUENTLY SENT TO FACILITIES FOR REPAIR; MOST OFTEN THE PRONGS THAT CONNECT THE BATTERY HAVE FLATTENED AND NO LONGER MAKE A CONNECTION RESULTING IN THE DEVICE FAILING TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832859 SAFE-T MATE MONITOR, BED PATIENT KMI 210 INNOVATION, LLC SM-004B *

    Patients

    Seq Age Sex Outcome Treatment
    1 *