BEUDAMED
    FDA Adverse Event Other Summary report: N

    BED-CHECK ST CHAIR SENSORMAT P.N. 73030

    MDR report key: 2163725 · Received July 7, 2011

    Report

    Report Number
    1929691-2011-00006
    Event Type
    Other
    Date Received
    July 7, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 26, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIVISION
    Product Code
    KMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, STANLEY RECEIVED THE BED-CHECK ST CHAIR SENSORMAT PAD MODEL # 73030 (L/N (B)(4)) CLAIMED TO BE IN USE AT THE TIME OF THE INCIDENT. ON (B)(4) 2011, STANLEY RECEIVED THE BED-CHECK CLASSIC-CHECK MONITOR MODEL #72020 (S/N (B)(4)) THAT WAS ALLEGED TO HAVE BEEN IN USE WITH THE ST CHAIR SENSORMAT. DURING STANLEY'S TESTING AND EVAL OF THIS EQUIPMENT, THE FOLLOWING WAS FOUND: THE BED CHECK CLASSIC-CHECK MONITOR MODEL # 72020 (S/N (B)(4)) FUNCTIONED ACCORDING TO MANUFACTURER SPECIFICATIONS. THE BED-CHECK ST CHAIR SENSORMAT PAD MODEL# 73030 FUNCTIONED ACCORDING TO MANUFACTURER SPECIFICATIONS WHEN RETURNED. HOWEVER, FURTHER DISSECTION UNCOVERED THAT THE MAT HAD SUSTAINED LIQUID DAMAGE NEAR THE INTERNAL CIRCUITRY AT USER FACILITY. THE UNK SUBSTANCE WAS NOT ONLY FOUND NEAR THE WIRES, BUT WAS APPARENT BY THE DISCOLORATION OF INTERNAL PARTS. THIS DAMAGE MAY HAVE LED TO THE ALLEGED FAILURE OR INTERMITTENT WORKING CONDITION. PER STANLEY'S INSTRUCTIONS, "DO NOT IMMERSE, ROLL, OR FOLD THE SENSORMAT" AND "TEST SYSTEM PERFORMANCE BEFORE USING DAILY AND THEREAFTER." THE CONCLUSION OF THE STAFF THAT EXAMINED THE MAT INDICATED THAT ANY DEFECT WAS DUE TO THE FAILURE OF THE END USER TO PROPERLY MAINTAIN THE MAT AS INDICATED BY THE MANUFACTURER. PER STANLEY'S CONVERSATION WITH (B)(6). ON (B)(6) 2011, THERE WERE NO INJURIES REQUIRING CARE BEYOND FIRST AID ASSOCIATED WITH THE ALLEGED FAILURE. (B)(4).

    Description of Event or Problem · 1

    (B)(6) REPORTED THE FOLLOWING ON (B)(6) 2011: "UN-OBSERVED FALL FROM CHAIR. PT BEING MONITORED WITH BED-CHECK CLASSIC CHECK AND ST CHAIR SENSORMAT (B)(4), WHILE SEATED IN A BEDSIDE CHAIR. ALARM WAS NOT TRIGGERED, FOLLOW-UP CHECK OF SENSORMAT SHOWS TO BE READING WEIGHT PRESENT WHEN NO PRESSURE IS APPLIED. PT SUFFERED LACERATION TO HEAD. SOME POINT LATER FOUND LAYING IN FLOOR." ON (B)(6) 2011, (B)(6) REPORTED TO STANLEY THAT AN INCIDENT HAD OCCURRED. HE REPORTED THAT THE MONITORING EQUIPMENT IN USE DID NOT ALARM AND THE PT WAS FOUND ON THE FLOOR. ON (B)(6) 2011, STANLEY RECEIVED THE BED-CHECK ST CHAIR SENSORMAT PAD MODEL #73030 ((B)(4)) CLAIMED TO BE IN USE AT THE TIME OF THE INCIDENT. ON (B)(6) 2011, STANLEY RECEIVED THE BED-CHECK CLASSIC-CHECK MONITOR MODEL #72020 (S/N (B)(4)) THAT WAS ALLEGED TO HAVE BEEN IN USE WITH THE ST CHAIR SENSORMAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED-CHECK ST CHAIR SENSORMAT P.N. 73030 CHAIR CHECK SENSOR PAD KMI STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIVISION 73030 (L/N C0510)

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other