BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO_TECH

    MDR report key: 2010705 · Received February 24, 2011

    Report

    Report Number
    1929691-2009-00003
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    October 27, 2009
    Report Date
    January 10, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC. - SENIOR TECHNOLOGIES DIVISON
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2009: (B)(6), DIRECTOR OF NURSING, INDICATED THAT SHE DID NOT KNOW IF SHE WOULD BE ABLE TO CONFIRM IF THE PAD WAS PLUGGED INTO THE MONITOR. THE FACILITY WAS USING ONE MONITOR AND SWITCHING BACK AND FORTH BETWEEN THE BED PAD AND THE CHAIR PAD. (B)(6) INDICATED THEY ARE NOW USING TWO ALARMS. ON (B)(6) 2009: (B)(6) WHO IS THE REGIONAL CONSULTANT RN AT (B)(6) STATED THAT PADS WOULD NOT ALARM AND WERE NOT FUNCTIONING PROPERLY. SUE CLAIMED THE FACILITY MAY NOT HAVE BEEN USING THE SAME BRAND OF MONITORS WITH THE SAME BRAND OF PADS. ON (B)(6) 2009: (B)(6) INDICATED THAT THE PADS INVOLVED IN THE ALLEGED FAILURES HAVE BEEN ADVISED NOT TO LEAVE HER OFFICE. NO EQUIPMENT WAS RETURNED TO (B)(6) FOR EVALUATION. IT IS UNKNOWN IF (B)(6) USED MICRO-TECH BED OR CHAIR SENSORS WITH MICRO-TECH MONITORS. THE REPORT ON (B)(6) 2009, (B)(6) INDICATED THAT THEY MAY NOT HAVE BEEN USING THE SAME BRAND OF MONITORS WITH THE SAME BRAND OF PADS.

    Description of Event or Problem · 1

    ANGIE PETERSON, DIRECTOR OF NURSING, INDICATED THAT THEY HAD UNITS FAIL OVER THE WEEKEND RESULTING IN ONE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO_TECH MICRO-TECH BED SENSOR KMI STANLEY SECURITY SOLUTIONS, INC. - SENIOR TECHNOLOGIES DIVISON 82715 NA

    Patients

    Seq Age Sex Outcome Treatment
    1