BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 15986897 · Received December 15, 2022

    Report

    Report Number
    9710055-2022-00520
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    October 13, 2022
    Report Date
    December 15, 2022
    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. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ON 13TH OCTOBER 2022, GETINGE BECAME AWARE OF A NON-REPORTABLE ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED 700. ON 9TH NOVEMBER 2022, DURING A SERVICE VISIT, THE TECHNICIAN DISCOVERED THAT THE CAP WAS MISSING FROM THE DEVICE. 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. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO A MISSING CAP, WHICH CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF UPON THE EVENT OCCURRENCE THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO OF THE INVESTIGATED ISSUE IS LOW. A ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AND IT WAS ESTABLISHED MAQUET SAS DID NOT RECEIVE ENOUGH INFORMATION TO CONDUCT THE TECHNICAL INVESTIGATION. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE NOR PROVIDE THE MOST PROBABLE ROOT CAUSES. IN CASE OF NEW RELEVANT INFORMATION, THE CASE WILL BE RECONSIDERED. GETINGE 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

    ON (B)(6)2022 GETINGE BECAME AWARE OF A NON-REPORTABLE ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED 700. ON (B)(6)2022., DURING SERVICE VISIT, THE TECHNICIAN DISCOVERED THAT CAP WAS MISSING FROM THE DEVICE. 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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440090 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568371939

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown