BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET POWERLED II

    MDR report key: 20732933 · Received November 20, 2024

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    Report

    Report Number
    9710055-2024-0000597
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 22, 2024
    Report Date
    November 19, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    UDI-DI
    03700712426279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF H4 MANUFACTURE DATE, D4 CATALOG #, UNIQUE IDENTIFIER (UDI) #, SERIAL#, VERSION OR MODEL #, B5 DESCRIBE EVENT AND PROBLEM, D1 BRAND NAME, D2A AND D2B PRODUCT CODE., B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 MANUFACTURE DATE: 2021-10-07 CORRECTED H4 MANUFACTURE DATE: 2023-10-19 PREVIOUS D1 BRAND NAME EQT CORRECTED D1 BRAND NAME MAQUET POWERLED II PREVIOUS D2A PRODUCT CODE. FXR CORRECTED D2A PRODUCT CODE. FTD PREVIOUS D2B PRODUCT CODE DESCRIPTION. HOLDER, CAMERA, SURGICAL CORRECTED D2B PRODUCT CODE DESCRIPTION. LAMP, SURGICAL PREVIOUS D4 CATALOG # ARD567711940 CORRECTED D4 CATALOG # BLANK PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: N/A CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). PREVIOUS D4 SERIAL # (B)(6). CORRECTED D4 SERIAL # (B)(6). PREVIOUS D4 VERSION OR MODEL # ARD567711940 CORRECTED D4 VERSION OR MODEL # ARDPWT639073A PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - EQT. IT WAS STATED THE MONITOR BOX FELL OFF DURING SUGERY, WHEN NURSE MOVED THE MONITOR. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS MONITOR FALLING OFF DURING PROCEDURE MAY CAUSE CONTAMINATION OF SURGERY TOOLS OR CAN CAUSE SERIOUS INJURY TO MEDICAL STAFF. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ POWERLED II. IT WAS STATED THE MONITOR BOX FELL OFF DURING SURGERY, WHEN NURSE MOVED THE MONITOR. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS MONITOR FALLING OFF DURING PROCEDURE MAY CAUSE CONTAMINATION OF SURGERY TOOLS OR CAN CAUSE SERIOUS INJURY TO MEDICAL STAFF. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ MAQUET POWERLED II. IT WAS STATED THE MONITOR BOX FELL OFF DURING SURGERY, WHEN NURSE MOVED THE MONITOR. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS MONITOR FALLING OFF DURING PROCEDURE MAY CAUSE CONTAMINATION OF SURGERY TOOLS OR CAN CAUSE SERIOUS INJURY TO MEDICAL STAFF. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THE CLAIMED DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. A ROOT CAUSE ANALYSIS WAS CONDUCTED BY THE SUBJECT MATTER EXPERT. AS STATED: THE REAR BOX 01 MAY NOT HAVE BEEN SECURED PROPERLY DURING THE INSTALLATION OR A MAINTENANCE. IT CAN BE CONSIDERED AS AN ISOLATED CASE. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - EQT. IT WAS STATED THE MONITOR BOX FELL OFF DURING SUGERY, WHEN NURSE MOVED THE MONITOR. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS MONITOR FALLING OFF DURING PROCEDURE MAY CAUSE CONTAMINATION OF SURGERY TOOLS OR CAN CAUSE SERIOUS INJURY TO MEDICAL STAFF.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ POWERLED II. IT WAS STATED THE MONITOR BOX FELL OFF DURING SURGERY, WHEN NURSE MOVED THE MONITOR. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS MONITOR FALLING OFF DURING PROCEDURE MAY CAUSE CONTAMINATION OF SURGERY TOOLS OR CAN CAUSE SERIOUS INJURY TO MEDICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995697 MAQUET POWERLED II LAMP, SURGICAL FTD MAQUET SAS ARDPWT639073A 03700712426279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown