BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODEL VR

    MDR report key: 1981138 · Received January 13, 2011

    Report

    Report Number
    1929691-2010-00007
    Event Type
    Other
    Date Received
    January 13, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 22, 2010
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIVISION
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ORIGINAL CONVERSATION WITH BIO-MED MANAGER AND WHEN THE INITIAL COMPLAINT WAS MADE ON (B)(6) 2011, MR. (B)(6) CLEARLY INDICATED NO INJURIES HAD TAKEN PLACE. AFTER RECEIVING THE MEDWATCH FORM WITH INCONSISTENCIES, MANY TIMES WE CONTACTED MR. (B)(6) IN AN ATTEMPT TO F/U AND HAVE THE EQUIPMENT RETURNED FOR PROPER EVALUATION. MR. (B)(6) DID NOT RETURN CALLS AFTER WE ATTEMPTED TO REACH HIM NUMEROUS TIMES. WITH NO ACCESS TO THE PRODUCT IN QUESTION, WE HAVE NO CHOICE BUT TO CLOSE THE COMPLAINT.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: ON THE FIRST INCIDENT THE BED SENSOR MAT WAS PROPERLY SET-UP AND TESTED PRIOR TO THE PT LAYING ON THE BED. IN THE MIDDLE OF THE NIGHT, IT WAS DISCOVERED THAT THE PT GOT OUT OF BED AND FELL. THE NURSING STAFF HEARD A LOUD NOISE COMING FROM THE PT'S ROOM. THE NURSING STAFF CAME IMMEDIATELY INTO THE PT'S ROOM AND DISCOVERED THE PT BY THE ROOM'S WHITE BOARD. THE BED ALARM SYSTEM DID NOT ALERT AS IT SHOULD HAVE. NO PT INJURY INFORMATION WAS PROVIDED. A SECOND OCCURRENCE WAS IN A DIFFERENT PT ROOM. THE BED ALARM SYSTEM WAS CONNECTED AND PROPERLY INSTALLED. AS THE STAFF WAS ASSESSING THE PT AND THE ALARM SYSTEMS, THE BED ALARM SYSTEM WENT OFF FEW SECONDS AFTER THE PT WAS STANDING IN THE ROOM. THE NURSING STAFF WAS PUZZLED AT THE DELAY. THE BED ALARM SYSTEM HAD BEEN WORKING PROPERLY PRIOR AND AFTER THE INCIDENT. NURSING STAFF ARE FRUSTRATED BECAUSE OF THE HIGH RATE OF PT FALLS. THE NURSING STAFF TOOK A CLOSER LOOK AT THE BED ALARM MAT AND NOTICED THERE WAS A CREASE IN THE MAT. IT LOOKS LIKE IF THERE IS A FOLD OR CREASE IN THE SENSOR MAT, IT WILL ACT AS IF THE PT IS STILL IN BED EVEN THOUGH THEY ARE NOT. THIS MAY HAVE BEEN¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL VR BED CHECK ALARM SYSTEM KMI STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIVISION VR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK