BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 8390467 · Received March 5, 2019

    Report

    Report Number
    9710055-2019-00055
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 8, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET SAS BECAME AWARE OF AN ISSUE WITH SURGICAL LIGHT POWERLED DEVICE. AS IT WAS STATED, THE RUST OCCURRED ON THE SPRING ARMS OF THE DEVICE AND RESULTED IN LOSS OF PAINT INTEGRITY. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLE FALLING INTO THE STERILE FIELD MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. DURING THE INVESTIGATION IT WAS FOUND THAT THERE IS NO APPARENT TREND AND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE. THE MANUFACTURER HAS PERFORMED AN INVESTIGATION FOR THAT CASE. THE MOST PROBABLE ROOT CAUSE IS THE COLLISION BETWEEN OTHER PRODUCTS SUCH AS THE SPRING ARM OR LIGHTHEAD. THE USER MANUALS INCLUDES THE INSTRUCTIONS TO PRE-POSITION THE ARMS PRIOR TO USE, IN ORDER TO PREVENT DAMAGES. TO PREVENT ANY OTHER SIMILAR CASE, MAQUET SAS RECOMMENDS TO DAILY CHECK THE DEVICE FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE (01581EN08, PAGE 38). WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION IN THE IFU WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. IF WE WILL RECEIVE MORE INFORMATION ABOUT THE ISSUE WE WILL UPDATE THE INVESTIGATION.

    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). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(4) 2019 MAQUET (B)(4) BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, THE RUST OCCURRED ON THE MAIN ARM. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLE FALLING MIGHT BE A SOURCE OF CONTAMINATION. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185709 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD567910902

    Patients

    Seq Age Sex Outcome Treatment
    1