BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED II

    MDR report key: 17963616 · Received October 19, 2023

    Report

    Report Number
    9710055-2023-00781
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 22, 2023
    Report Date
    October 19, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER: NILLEVILLE / SBO ST CLOUD. 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 H4 MANUFACTURE DATE, H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 MANUFACTURE DATE: 2019-07-10 CORRECTED H4 MANUFACTURE DATE: 2019-07-11 PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ PWDII700DF V K3 AIM CL. IT WAS DISCOVERED THAT THE UPPER WHITE COVER OF THE DOME WAS BROKEN. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND INDICATED THAT SOME PARTICLES WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S. ACCORDING TO SUBJECT MATTER EXPERT KNOWLEDGE, THE UPPER COVER BROKE DUE TO A COLLISION. GETINGE SHALL CONTINUE TO MONITOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6), 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE UPPER WHITE COVER OF THE DOME WAS BROKEN. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND ALSO INDICATED THAT SOME PARTICLES WHERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES 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
    66319 POWERLED II LAMP, SURGICAL FTD MAQUET SAS ARD569201917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown