BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED-CHECK

    MDR report key: 2250868 · Received September 15, 2011

    Report

    Report Number
    1929691-2011-00010
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    July 24, 2011
    Report Date
    September 8, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC, SENIOR TECHNOLOGIES DIV
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, SHS RECEIVED THE BED-CHECK VR MONITOR MODEL # 72030 (B)(4). SHS ALSO RECEIVED A BED-CHECK SENSORMAT PAD MODEL # 74010 (L/N 031411). HOWEVER, WE CANNOT BE CERTAIN THIS SENSORMAT WAS USED AT THE TIME OF THE INCIDENT AS (B)(6), ACCORDING TO (B)(4), HAD REPORTED THAT THE PAD HAD BEEN DISPOSED OF. DURING OUR INSPECTION OF THE PRODUCT, WE FOUND THE FOLLOWING: THE BED-CHECK VR MONITOR MODEL 72030 (B)(4) FUNCTIONED ACCORDING TO MFR SPECS. THIS IS THE ACTUAL DEVICE INVOLVED IN INCIDENT. THE BED-CHECK SENSORMAT MODEL # 74010 (L/N 031411) WAS FOUND TO HAVE A MFG DEFECT WITH INTERNAL CONNECTION. FACILITY ALLEGEDLY DISPOSED OF THE ORIGINAL MAT INVOLVED IN THE INCIDENT. SHS HAS REVIEWED ITS INTERNAL DOCUMENTS AND PROCEDURES AND HAS CONFIRMED THAT L/N 031411 FOR MODEL #74010 IS ISOLATED TO THIS ONE RETURN. SHS REMINDED CUSTOMER TO TEST THE PRODUCT BEFORE EACH AND EVERY USE WITH A PT TO ENSURE THE EQUIPMENT IS MONITORING APPROPRIATELY PER THE USER INSTRUCTIONS.

    Description of Event or Problem · 1

    STANLEY SECURITY SOLUTIONS, INC (SHS) RECEIVED NOTIFICATION FROM OUR DISTRIBUTOR, (B)(4) INDICATING THAT A FALL INCIDENT HAD OCCURRED AT (B)(6). THE ISSUE REPORTED WAS THAT THE PT LEFT THE BED AND FELL AND FACILITY CLAIMED THAT THE BED-CHECK CONTROL UNIT DID NOT ALARM. MEDICAL TECHNOLOGIES INDICATED THAT THEY RETRIEVED THE MONITOR BUT THAT (B)(6) DID NOT KEEP THE PAD THAT WAS IN USE AT THE TIME OF THE INCIDENT AS IT HAD BEEN DISPOSED OF, AND IT THEREFORE COULD NOT BE RETURNED FOR TESTING AND EVAL HERE AT SHS. FACILITY REPORTED ON (B)(6) 2011 THAT THE INCIDENT OCCURRED ON (B)(6) 2011 AND THAT THE RESIDENT SUSTAINED A FRACTURED LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED-CHECK VR MONITOR, SENSORMAT PAD KMI STANLEY SECURITY SOLUTIONS, INC, SENIOR TECHNOLOGIES DIV 72030 74010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other