BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 17744327 · Received September 14, 2023

    Report

    Report Number
    9710055-2023-00701
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 14, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF D4 CATALOG # DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG #: AR040054. CORRECTED D4 CATALOG #: AR040054/AR040348. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO THE REPORTED DEFECT, WHICH CONTRIBUTED TO THE REPORTABLE SITUATION. THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT UPON THE EVENT OCCURRENCE. THE ISSUE WAS DISCOVERED BY GETINGE TECHNICIAN WHO WAS PERFORMING THE SERVICE. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. COMPARING THE NUMBER OF AFFECTED DEVICES BY THE INVESTIGATED ISSUE TO THE INSTALL BASE, COMPLAINT RATIO IS LOW. AS PER EXPERTISE PERFORMED BY THE SUBJECT MATTER EXPERT AT MANUFACTURING SITE, THE POSSIBLE ROOT CAUSES ARE: - NON-CONFORMITY OF THE METAL COVERS ASSEMBLY. - DEGRADATION OF THE METAL COVERS. - IMPROPER USE (COLLISION WITH ANOTHER DEVICE) MAQUET SAS ANALYSIS SHOWS THAT THE METAL STRIP COMES OUT OF THE COVERS WHEN IT IS NOT CLIPPED PROPERLY. IN THE SCOPE OF OUR CONTINUOUS IMPROVEMENT POLICY, MAQUET SAS INITIATED A MODIFICATION FILE (E131106) TO INCLUDE THIS DUST COVER FITTING PROCEDURE IN THE TECHNICAL DOCUMENTATIONS WITH ALL SPRING ARMS. WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION HAD BEEN FOLLOWED THE REPORTED SITUATION WOULD HAVE BEEN AVOIDED. GIVEN THE FINDINGS OF THIS INVESTIGATION GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY OTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON 5TH SEPTEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE DUST COVER WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362606 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568415010C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown