BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMP

    MDR report key: 5001138 · Received June 4, 2015

    Report

    Report Number
    1929691-2015-00002
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    April 21, 2015
    Report Date
    June 4, 2015
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ITEMS OF EXTERNAL VISUAL DAMAGE NOTED. NEGATIVE BATTERY CONNECTION IN BATTERY COMPARTMENT WAS DEFORMED AND PRESSED IN AS RECEIVED. MONITOR DID NOT FUNCTION AS RECEIVED, AS NEGATIVE BATTERY TERMINAL WAS DEFORMED, AND CONTACT WOULD NOT BE MADE WITH THE NEGATIVE POST OF THE BATTERY. THE BATTERY CONNECTION COULD BE FORCED BY INSERTING AN APPROXIMATELY 1/4 INCH THICK NUT BETWEEN THE BOTTOM OF THE BATTERY AND THE BATTERY COMPARTMENT. USER DAMAGE IN INSERTING A FOREIGN OBJECT IN THE BATTERY COMPARTMENT, POSSIBLY IN AN ATTEMPT TO ESTABLISH BATTERY CONNECTION, DEFORMING BATTERY TERMINALS. REPLACEMENTS WERE PROVIDED TO FACILITY.

    Description of Event or Problem · 1

    ON 05/05/2015, (B)(4) RECEIVED REPORT FROM A DISTRIBUTOR THAT A UMP PULL-STRING MONITOR FAILED TO ALARM WHEN A RESIDENT GOT OUT OF BED AND FELL. FURTHER INFORMATION GATHERED INDICATED TWO SUCH INCIDENTS HAD OCCURRED. IN THE FIRST INCIDENT, OCCURRING (B)(6) 2015, THE RESIDENT WAS MONITORED IN BED DURING NIGHT SHIFT AND FELL, SUFFERING A BROKEN HIP REQUIRING SURGERY TO REPAIR. IN THE SECOND INCIDENT, OCCURRING (B)(6) 2015, THE RESIDENT WAS MONITORED IN A CHAIR DURING NIGHT SHIFT AND FELL, SUFFERING A BROKEN TIBIA REQUIRING SURGERY TO REPAIR. FACILITY REPORTED THAT BOTH SURGERIES WERE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363901 UMP BED-PATIENT MONITOR KMI STANLEY SECURITY SOLUTIONS, INC. 91230 R0914; P0814

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention