BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5-POLE SPRING ARM AC 2000 15-21 KG

    MDR report key: 7499793 · Received May 9, 2018

    Report

    Report Number
    0002031963-2018-00004
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 9, 2018
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE M3 SCREW ON LIGHT 2 SAFETY COLLAR IS IN PLACE, BUT IS NOT THE CORRECT ¿FACTORY¿ SCREW. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED TO FOR INVESTIGATION. THE SFST ENTERED OR15 AND FOUND THE M3 SCREW WAS IN FACT THE INCORRECT SCREW FOR THE SPRING ARM COLLAR. WHILE IT IS UNKNOWN AS TO WHY A DIFFERENT M3 SCREW WAS NOT PRESENT THE MOST LIKELY ROOT CAUSE IS IMPROPER MAINTENANCE BY FACILITY. THE SFST INSTALLED THE REPLACEMENT SCREW AND ENSURED THE COLLAR WAS SECURELY IN PLACE. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN OR15 THAT THE M3 SCREW ON LIGHT 2 SAFETY COLLAR IS IN PLACE, BUT IT IS NOT THE CORRECT ¿FACTORY¿ SCREW. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340530 5-POLE SPRING ARM AC 2000 15-21 KG LIGHT, SURGICAL, CEILING MOUNTED FSY STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1