BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 8653420 · Received May 30, 2019

    Report

    Report Number
    9710055-2019-00185
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 27, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, ONE FOR THE SIX SCREWS HAS THE HEAD CUT. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DEFECT OF THE SCREWS INVOLVED IN THIS COMPLAINT MAY LEAD TO THE DETACHMENT OF THE WHOLE CONFIGURATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION. THERE IS NO INFORMATION IF AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR THE PATIENT TREATMENT. MECHANICAL FATIGUE MAY HAVE DIFFERENT ORIGINS, INCLUDING BUT NOT LIMITED TO A SCREWING TORQUE NON-COMPLIANT WITH SPECIFICATIONS APPLIED DURING INSTALLATION OR PERIODIC MAINTENANCE, A MISUSE OR UNEXPECTED HANDLING OF THE DEVICE OR A SCREW DESIGN NOT ADAPTED TO THE INTENDED USE. THE INVESTIGATIONS PERFORMED UNTIL TODAY COULD NOT CONFIRM OR REMOVE ANY OF THESE OPTIONS EXCEPT THE DESIGN OF THE DEVICE. WE BELIEVE THAT CURRENTLY AND OVERALL, THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET WITH REGARDS TO THE REPORTED ISSUE.

    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. H3 OTHER TEXT: DEVICE NOT RETURNED BY MANUFACTURER.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON 28TH MAY, 2019 MAQUET SAS BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, ONE FOR THE SIX SCREWS HAS THE HEAD CUT. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DEFECT OF THE SCREWS INVOLVED IN THIS COMPLAINT MAY LEAD TO THE DETACHMENT OF THE WHOLE CONFIGURATION.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    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

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER'S 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
    446328 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1