BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-TECH

    MDR report key: 2132480 · Received June 16, 2011

    Report

    Report Number
    1929691-2011-00005
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIV.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT FROM (B)(4) (FROM (B)(6)) WAS RECEIVED ON (B)(4) 2011 AND CONSISTED OF A MICRO-TECH CHAIR SENSOR PAD MODEL # 83720 ((B)(4)) AND MICRO-TECH BED SENSOR PAD # 82710 (LOT # 051000409). DURING (B)(4) TESTING AND EVAL OF THIS EQUIPMENT, THE FOLLOWING WAS FOUND: THE MICRO-TECH CHAIR SENSOR PAD MODEL # 83720 ((B)(4)) WAS DISCOVERED TO HAVE SUSTAINED DAMAGE TO THE CORD. THE CORD SHOWED SIGNS THAT EXCESSIVE FORCE HAD BEEN APPLIED, POSSIBLY FROM BEING STRETCHED, CAUSING THE COPPER TO BECOME EXPOSED INSIDE THE INSULATION WHICH IN TURN CAUSED A SHORT. THE MICRO-TECH BED SENSOR PAD # 82710 (LOT # 051000409) WAS DISCOVERED TO HAVE SUSTAINED DAMAGE TO THE CORD. THE CORD SHOWED SIGNS THAT EXCESSIVE FORCE HAD BEEN APPLIED, POSSIBLY FROM BEING STRETCHED, WHICH CAUSED THE COPPER TO BECOME EXPOSED INSIDE THE INSULATION, CAUSING AN OPEN CONNECTION. THE RETENTION TAB THAT SECURES THE CONNECTOR IN THE MONITOR HAD ALSO BEEN DAMAGED AND WAS MISSING. THE MONITOR INVOLVED IN THE INCIDENT WAS NOT RETURNED TO (B)(4) FOR EVAL, AS IT COULD NOT BE LOCATED AT (B)(6). HOWEVER, OUR FINDINGS CONCLUDE THAT THE MATS AS RETURNED WOULD NOT HAVE FUNCTIONED PROPERLY DUE TO THE DAMAGE SUSTAINED TO THE CORDS. ADD'L MODEL #: 82710. (B)(4). ADD'L MANUFACTURE DATE: 05/2010.

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6) REPORTED THAT A FALL HAD OCCURRED AT (B)(6) AND THAT THE EQUIPMENT IN USE ALLEGEDLY DID NOT ALARM. (B)(6) RISK MGMT AT (B)(6), REPORTED THAT ON (B)(6) 2011 A RESIDENT WAS IN HER BED, BUT WAS LATER DISCOVERED ON HER RIGHT SIDE ON THE FLOOR AFTER STAFF ALLEGEDLY HEARD A DELAYED ALARM. RISK MGMT INDICATED THAT THE RESIDENT HAD SUSTAINED A BROKEN HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-TECH CHAIR AND BED SENSOR PAD KMI STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIV. 83720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization