BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED-CHECK

    MDR report key: 4381470 · Received December 31, 2014

    Report

    Report Number
    1929691-2014-00003
    Event Type
    Injury
    Date Received
    December 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    December 31, 2014
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, NO HOSPITAL STAFF MEMBER HAS SPOKEN WITH ANY MANUFACTURER REPRESENTATIVE REGARDING THIS INCIDENT DESPITE REPEATED CALLS FOR INFORMATION, THEREFORE, NO FIRM CONFIRMATION WAS GATHERED WITH RESPECT TO THE FILING OF ANY MDR. NO MDR HAS TO DATE BEEN FORWARDED TO MANUFACTURER FROM FDA-CDRH. ATTORNEY STEVENS REPORTED THAT HE DID NOT BELIEVE THAT AN MDR WAS FILED BY THE USER FACILITY WITH THE FDA. USER FACILITY REPORTED AS (B)(6). INCIDENT EQUIPMENT IS SEQUESTERED AND WILL NOT BE RETURNED TO MANUFACTURER FOR INSPECTION AND/OR REPAIRS PER NORMAL PROCESS. THEREFORE, NO FIRM CONCLUSIONS CAN BE DRAWN AS TO POSSIBLE CAUSES OF INCIDENT AT THE TIME OF THIS REPORT. BASED ON THE NURSING REPORT RECEIVED, THE MONITOR ALARMED LOCALLY, BUT AN ALARM SIGNAL WAS NOT RECEIVED BY THE FACILITY'S NURSE CALL SYSTEM. THEREFORE, THERE WAS LIKELY NO FAILURE OF THE MONITOR OR PAD, AND FAILURE OF TRANSMISSION OF ALARM TO NURSE CALL SYSTEM IS UNKNOWN. NO DETAILS OF SUSPECT NURSE CALL SYSTEM (MAKE, MODEL, ETC.) HAVE BEEN GATHERED TO DATE.

    Description of Event or Problem · 1

    FROM NURSING REPORT TRANSMITTED BY REPORTER: "AT 1540 (B)(6) BEGAN YELLING OUT FOR HELP FROM ROOM 469. WHEN I GOT TO THE ROOM THE BED ALARM WAS GOING OFF, BUT DID NOT GO OFF AT THE DESK OR TO THE PAGERS, AND (B)(6) WERE IN THE BATHROOM AND MR. (B)(6) WAS LYING IN THE FLOOR. (B)(6) SAID THAT SHE WAS COMING OUT OF 467 AND HEARD THE "(B)(6) HAD A LITTLE LAMB" ALARM [SIC] GOING OFF IN 469. WHEN SHE GOT IN THE ROOM, MR. (B)(6) WAS ON THE BATHROOM FLOOR. MR. (B)(6) FELL AND LANDING ON HIS LEFT HIP AND HIT THE LEFT SIDE OF HIS HEAD ON THE WALL. HE STATED THAT HE WAS TRYING TO GO TO THE BATHROOM AND KNEW THAT HE SHOULD HAVE CALLED AND ASKED FOR HELP. HE IS ALERT AND ORIENTED. (B)(6) AND I STOOD HIM BACK UP AND BEGAN TO WALK HIM BACK TO THE BED AND HE WAS UNABLE TO PUT ANY WEIGHT ON THAT LEFT LEG. HE HAS SINCE BEEN COMPLAINING OF SEVERE PAIN IN THAT LEFT HIP AND UPPER LEG. (B)(6) CONTACTED THE DOCTOR AND NOTIFIED HIM OF THE EVENT AND A X-RAY OF HIS HIP AND LEG WERE ORDERED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863713 BED-CHECK MONITOR, BED-PATIENT KMI STANLEY SECURITY SOLUTIONS, INC. VR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death UNK, TREATMENT FOR CHF. UNK NURSE CALL.