BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 8854609 · Received August 2, 2019

    Report

    Report Number
    9710055-2019-00224
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 25, 2019
    Report Date
    March 18, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF INCIDENT WITH ONE OF THE SURGICAL LAMP - POWERLED 500+ DF HD QL K3. AS IT WAS STATED, THE LIGHT HEAD DROPPED FROM THE SPRING ARM DURING CLEANING PROCEDURE. NO INJURY WAS REPORTED DUE TO THE MENTIONED CASE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AS IT WAS FOUND THAT THERE WAS A MISSING SCREW THEREFORE TECHNICAL DEFICIENCY WAS CONFIRMED AND IT CONTRIBUTED TO THE EVENT. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR THE PATIENT TREATMENT. UPON THE PERFORMED INVESTIGATION IT WAS ESTABLISHED THAT THE EVENT OCCURRED AS A COMBINATION OF THREE DIFFERENT FACTORS: A MISSING SCREW, THE VERTICAL MOTION OF THE SAFETY SLEEVE AND THE TRANSITION OF THE SAFETY SEGMENT. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THE OCCURRENCE RATE IS CONSIDERED TO BE LOW WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: 233647.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. DEVICE NOT RETURNED BY MANUFACTURER.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, THE LIGHTHEAD HAS FALLEN AND THE SPRINGARM WENT INTO THE CEILING. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING MIGHT BE A SOURCE OF AN INCIDENT. MANUFACTURER'S REFERENCE NUMBER : (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

    MANUFACTURER'S 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
    650073 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568351938 - LIGHT HEAD

    Patients

    Seq Age Sex Outcome Treatment
    1