BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 7845454 · Received September 5, 2018

    Report

    Report Number
    9710055-2018-00079
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 8, 2018
    Report Date
    October 29, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 (B)(4). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT POWERLED DEVICE. AS IT WAS STATED BY THE CUSTOMER THE BUMPER OF A SURGICAL LIGHT FELL OFF INTO STERILE FIELD. THE BUMPER PART 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 SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED SCENARIO HAS TO DATE NOT 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 CAN HAPPEN WHEN THE USER IS NOT BEING CAREFUL WITH MOVING THE DEVICE ARMS AND LIGHTS. TO PREVENT ANY OTHER CASES, MAQUET SAS RECOMMENDS IN POWERLED USER MANUAL 01581EN ED. 06 ON PAGE 40 THAT DURING THE ANNUAL CHECK WHICH SHOULD BE PERFORMED BY AN AUTHORIZED TECHNICIAN THE LOOSENESS OF COVERS AND CAPS MUST BE CHECKED. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION.

    Additional Manufacturer Narrative · 0

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. 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).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, THE END CAP FELL OFF OF THE DEVICE. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690062 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1