BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABS

    MDR report key: 4269435 · Received October 16, 2014

    Report

    Report Number
    1929691-2014-00001
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    August 30, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICES WERE EVALUATED, AND WERE IN NEED OF MAINTENANCE/REPLACEMENT OF PARTS. ELECTRICAL TESTING REVEALED AN INTERMITTENT CONNECTION BETWEEN TE MONITOR AND PAD THAT DID NOT ALLOW PAD CIRCUIT CLOSURE TO BE DETECTED BY THE MONITOR. DISCUSSED TESTING INSTRUCTIONS IN USER MANUAL, AND FACILITY WAS NOT TESTING BEFORE EACH USE. FAILURES OF TESTING BEFORE EACH USE SHOULD LEAD TO REMOVAL FROM SERVICE AND RETURN TO MANUFACTURER FOR MAINTENANCE/INSPECTION. DEVICES RETURNED WERE REPAIRED BY REPLACING THE NURSE CALL AND PAD CONNECTION JACKS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    FROM MEDWATCH FORM RECEIVED FROM USER FACILITY: "PATIENT WAS FALL RISK SO BED EXIT ALARM PLACED ON BED. PATIENT FOUND ON FLOOR BUT TABS MONITOR DID NOT ALARM. CHANGED ALARM BOX. PATIENT FOUND OUTSIDE HOSPITAL IN ALLEY BY POLICE. SECOND TABS BOX DID NOT ALARM. PATIENT HAD ABRASIONS, PAIN." FURTHER CONTACT WITH FACILITY REVEALED THAT NO SERIOUS INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656664 TABS BED EXIT ALARM KMI STANLEY SECURITY SOLUTIONS, INC. 25222 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other NONE LISTED