BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABS PROFESSIONAL

    MDR report key: 4606438 · Received March 10, 2015

    Report

    Report Number
    1929691-2015-00001
    Event Type
    Injury
    Date Received
    March 10, 2015
    Date of Event
    January 29, 2015
    Report Date
    March 10, 2015
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONDUCTED, AND THE CLIP ASSEMBLY RETURNED WITH THE MONITOR WAS FOUND WORN. MONITOR OTHERWISE OPERATED ACCORDING TO SPECIFICATIONS ON TESTING. PULL TESTS WERE CONDUCTED ON THE MONITOR SHUNT AND CLIP ASSEMBLY AS RETURNED. PULL FORCE FOR THE SHUNT WAS FOUND WITHIN SPECIFICATIONS, AND HOLDING FORCE OF CLIP WAS TESTED IN VARYING CONFIGURATIONS. HOLDING FORCE OF CLIP WAS FOUND TO EXCEED THE SHUNT PULL OUT FORCE IN ALL CASES EXCEPT WHEN TESTED ON A SINGLE LAYER OF FABRIC WITH NO SEAM AND WITH THE CLIP NOT LOCKED INTO PLACE. WARNINGS IN PRODUCT USER GUIDE INSTRUCTS USER TO INSPECT CORD AND CLIP ASSEMBLY BEFORE EACH USE, AND TO DISCARD AND REPLACE WORN COMPONENTS BEFORE USE. MANUFACTURER THEREFORE CONCLUDES THAT OPERATOR TECHNIQUE IN APPLYING CLIP MAY HAVE BEEN INSUFFICIENT, OR ALTERNATIVELY THAT RESIDENT PURPOSEFULLY REMOVED CLIP BEFORE GETTING OUT OF BED.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED REPORT BY PHONE FROM USER FACILITY THAT A TABS MONITOR USED WITH CORD AND CLIP ASSEMBLY FAILED TO ALARM WHEN A RESIDENT GOT OUT OF BED AND FELL, DUE TO THE CLIP COMING OFF THE RESIDENT'S CLOTHING. FACILITY REPORTED THAT THE INCIDENT OCCURRED ON (B)(6)2015, AND RESULTED IN A FRACTURED HIP, AND AFTER SUCCESSFUL SURGERY THE RESIDENT EXPIRED ON OR ABOUT (B)(6) 2015. THE FACILITY FURTHER REPORTED THAT THE CLIP ASSEMBLY IN THIS CASE WAS APPLIED TO THE RESIDENT'S FLANNEL NIGHTSHIRT, AND THAT THE FACILITY HAD LATER TAKEN CORRECTIVE ACTION BY REMOVING ALL CORD AND CLIP ASSEMBLIES PRESENTLY IN USE, REPLACING THEM WITH A PRODUCT KNOWN AS "PRIME SNAPS" NOT MADE BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163443 TABS PROFESSIONAL MONITOR, BED-PATIENT KMI STANLEY SECURITY SOLUTIONS, INC. 25023

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O