BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED-CHECK CLASSIC-CHECK; IT BED SENSORMAT

    MDR report key: 2740514 · Received September 11, 2012

    Report

    Report Number
    1929691-2012-00005
    Event Type
    Injury
    Date Received
    September 11, 2012
    Date of Event
    July 17, 2012
    Report Date
    August 29, 2012
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY IS AS OF THIS REPORT UNWILLING TO RETURN ACTUAL DEVICES INVOLVED IN THIS INCIDENT FOR A MANUFACTURER'S EVALUATION. AS THE REPORT FROM THE FACILITY STATES, THE MONITOR DID SIGNAL AN AUDIBLE, LOCAL ALARM WHICH TRIGGERED A RESPONSE BY NURSING STAFF. FACILITY REPORTED CONDUCTING FUNCTIONAL TESTING OF THE ACTUAL UNIT INVOLVED IN THE INCIDENT. BOTH THE BED-CHECK MONITOR AND SENSORMAT PAD PERFORMED NORMALLY, ACCORDING TO THE FACILITY'S REPORT. THE FACILITY ALSO REPORTED TESTING THE NURSE CALL CABLE USED TO CONNECT THE MONITOR TO THE NURSE CALL SYSTEM WITH A FLUKE MULTIMETER. ON THIS TESTING, THE NURSE CALL CABLE FAILED CONTINUITY TESTING. BASED ON FACILITY'S REPORT OF THE INCIDENT AND TESTING, MANUFACTURER SUSPECTS THAT THE BED-CHECK CLASSIC-CHECK MONITOR AND SENSORMAT PAD OPERATED CORRECTLY AT THE TIME OF THE INCIDENT, AS EVIDENCED BY FACILITY'S REPORT THAT NURSING STAFF RESPONDED TO THE LOCAL ALARM. MANUFACTURER ALSO SUSPECTS THAT A CALL WAS NOT RECEIVED BY FACILITY'S NURSE CALL SYSTEM, AS EVIDENCED BY THE FAILURE OF CONTINUITY OF THE NURSE CALL CABLE POST-INCIDENT ON TESTING CONDUCTED BY THE FACILITY. WITHOUT EVALUATING THE NURSE CALL SYSTEM, MANUFACTURER CANNOT SPECULATE AS TO WHAT MAY HAVE CAUSED THE FAILURE OF CONTINUITY. MANUFACTURER WILL STRONGLY RECOMMEND THAT FACILITY RETURN ALL ITEMS INVOLVED IN THIS INCIDENT FOR EVALUATION IN FORMAL LETTER SENT TO FACILITY.

    Description of Event or Problem · 1

    NURSING STAFF AT FACILITY REPORTED THAT PATIENT GOT UP FROM BED AND FELL, SUFFERING A FRACTURED FEMUR THAT REQUIRED SURGICAL REPAIR. NURSING STAFF REPORTED RESPONDING TO LOCAL ALARM GENERATED BY BED-CHECK FALL MONITORING SYSTEM WHEN STAFF PASSED BY THE ROOM. REPORT CANNOT AFFIRM OR DENY WHETHER THE FACILITY'S NURSE CALL SYSTEM RECEIVED THE ALARM. FACILITY REPORTED FILING THIS INCIDENT UNDER UF REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED-CHECK CLASSIC-CHECK; IT BED SENSORMAT BED-CHECK KMI STANLEY SECURITY SOLUTIONS, INC. 74010; 72020 E0212 (SENSORMAT)

    Patients

    Seq Age Sex Outcome Treatment
    1 U/K Hospitalization U/K