BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSES PULSE

    MDR report key: 21000041 · Received December 23, 2024

    Report

    Report Number
    2124215-2024-80484
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 5, 2024
    Report Date
    February 20, 2025
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    UDI-DI
    07290109145525
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE CONSOLE'S CERAMIC FUSE WAS REPLACED DURING A FIELD SERVICE, AND THE ISSUE WAS RESOLVED. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION CONCLUSION CODE SELECTED FOR THIS COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE.

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS SERVICED BY THE FIELD SERVICE ENGINEER (FSE) AT THE CUSTOMER'S SITE. THE FSE REVIEWED THE ERROR LOGS AND DISCOVERED ERROR 188 (COOLING SYSTEM ERROR-COOLING FLOW SWITCH ERROR). THE ERROR WAS CAUSED BY A BLOWN FUSE. THE FSE REPLACED THE CERAMIC FUSE ASSEMBLY. FOLLOWING THE REINSTALL, CONSOLE WAS RECALIBRATED TO MEET THE MANUFACTURER SPECIFICATIONS. THE CERAMIC FUSE ASSEMBLY WAS RECEIVED AT OUR QUALITY ASSURANCE LABORATORY AND UNDERWENT THROUGH ANALYSIS. VISUAL INSPECTION NOTED THAT THE CERAMIC FUSE ASSEMBLY ARRIVED DISASSEMBLED. NO FURTHER TESTING WAS PERFORMED. BASED ON ANALYSIS RESULTS, AND AFTER THE FSE CHANGED THE CERAMIC FUSE ASSEMBLY THE REPORTED EVENT WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSOLE DID NOT POWER UP DURING THE PREPARATION. THE MACHINE WAS TRIED TO PLUG AND UNPLUG THREE TIMES AND MOVED TO A DIFFERENT ROOM, BUT THE PROBLEM PERSISTED. THE PROCEDURE WAS CANCELED DUE TO THIS ISSUE. THE PATIENT WAS UNDER GENERAL ANESTHESIA, AND THERE WERE NO COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSOLE DID NOT POWER UP DURING THE PREPARATION. THE MACHINE WAS TRIED TO PLUG AND UNPLUG THREE TIMES AND MOVED TO A DIFFERENT ROOM, BUT THE PROBLEM PERSISTED. THE PROCEDURE WAS CANCELED DUE TO THIS ISSUE. THE PATIENT WAS UNDER GENERAL ANESTHESIA, AND THERE WERE NO COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSOLE DID NOT POWER UP DURING THE PREPARATION. THE MACHINE WAS TRIED TO PLUG AND UNPLUG THREE TIMES AND MOVED TO A DIFFERENT ROOM, BUT THE PROBLEM PERSISTED. THE PROCEDURE WAS CANCELED DUE TO THIS ISSUE. THE PATIENT WAS UNDER GENERAL ANESTHESIA, AND THERE WERE NO COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88216 MOSES PULSE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD GA-0006802 0000000128 07290109145525

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown