BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 7306272 · Received March 1, 2018

    Report

    Report Number
    9710055-2018-00009
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    February 1, 2018
    Report Date
    April 26, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT POWERLED DEVICE. AS IT WAS STATED BY THE CUSTOMER, THE END CAP OF THE CENTER MOUNT FELL OFF DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY. BUMPER IS USED TO COVER THE BOTTOM OF THE MAIN TUBE AND ACCESS TO CABLES INSIDE THE SURGICAL LIGHT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT-HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN EVENT OCCURRED THE DEVICE WAS USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. AS PER PERFORMED TESTS THE ROOT CAUSE OF FALLING BUMPER IS LIKELY CAUSED BY SEVERAL VIOLENT COLLISIONS WITH THE CUPOLAS, THIS HAPPENS WHILE THE USER IS NOT BEING CAREFUL WITH MOVING THE DEVICE ARMS AND LIGHTS. THE PRODUCT USER MANUAL 01581EN ED. 06 ON PAGE 11 INCLUDES AN INFORMATION THAT THE SAFETY AND INTEGRITY OF THE OPERATION OF THE PRODUCT ARE GUARANTEED ONLY IF ALL INSPECTION, MAINTENANCE AND REPAIR OPERATIONS ARE PERFORMED BY A MAQUET ENGINEER OR AN AUTHORIZED TECHNICIAN. UNFORTUNATELY, DUE TO THE LIMITED INFORMATION AVAILABLE, WE WERE NOT ABLE TO ESTABLISH THE EXACT ROOT CAUSE AND SEQUENCE OF EVENTS WHICH HAVE LED TO THE ISSUE COVERED BY THIS INVESTIGATION. AFTER REVIEWING THE HISTORY OF SIMILAR COMPLAINTS FROM THE PAST AND PER PREVIOUSLY PERFORMED TESTS, IT WAS ESTABLISHED THAT MOST PROBABLE ROOT CAUSE OF FALLING BUMPER IS VIOLENT INTERACTION OF THE DEVICE, FOR EXAMPLE CAUSED BY NOT BEING CAREFUL WITH MOVING THE CUPOLAS. THIS INCIDENT MIGHT BE AVOIDED IF THE CUSTOMER WAS FOLLOWING MAINTENANCE INSTRUCTION AND MAINTAIN THE DEVICE REGULARLY USING AUTHORIZED MAQUET SERVICE TECHNICIAN. TAKING UNDER CONSIDERATION ALL ABOVE AND THE FACT THAT THE CUSTOMER MAY HAVE BEEN USING ITS OWN SERVICE TECHNICIAN TO PERFORM CHECKS AND REPAIRS WE CANNOT EXCLUDE EITHER A USER ERROR LINKED TO COLLISION OF THE DEVICE OR THE MAINTENANCE NOT HAVING BEEN PERFORMED CORRECTLY. FROM THIS IT MAY BE THE CASE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD LIKELY HAVE BEEN AVOIDED.

    Description of Event or Problem · 0

    MANUACTURER REFERENCE NUMBER #(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, THE END CAP OF THE MAIN TUBE FELL OFF LIGHT INTO STERILE FIELD DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151781 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1