BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQT

    MDR report key: 16528753 · Received March 13, 2023

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    Report

    Report Number
    9710055-2023-00207
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Report Date
    March 13, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER?, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE -EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. 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 OUR EQUIPMENT. AS IT WAS STATED THE LABEL WAS CHIPPING OFF. 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. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE MAQUET EQUIPMENT DID NOT MEET ITS SPECIFICATION, DUE TO LABEL CHIPPING, WHICH COULD BE CONSIDERED AS TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. IT REMAINS UNKNOWN WHETHER THE AFFECTED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT OCCURRED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, IT WAS CONFIRMED THAT IN THE LAST 5 YEARS, REGISTERED FOR THE ISSUE OF LABEL CHIPPING OR MISSING ON MAQUET EQUIPMENT, THERE IS NO EVENT WHICH LED TO THE SERIOUS INJURY. COMPARING THE NUMBER OF CLAIMED DEVICES TO NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO FOR THE ISSUE INVESTIGATED HEREIN IS VERY LOW. AS STATED BY THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE, LABEL PEELING IS PROBABLY DUE TO COLLISION OR REPEATED EXCESSIVE RUBBING DURING CLEANING OF THE DEVICE, THE USE OF AGGRESSIVE OR UNSUITABLE CLEANING AGENTS MAY BE A CONTRIBUTING FACTOR. THE USER MANUAL MENTIONS TO CHECK THE LIGHTHEADS FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGES DURING DAILY CHECKS. TO PREVENT ANY INCIDENT SIMILAR TO THE LABEL MISSING, THE USER MANUAL MENTIONS INSTRUCTIONS CONCERNING CLEANING AND DISINFECTION, RECOMMENDED AND PROHIBITED PRODUCTS. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 11TH JANUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EQUIPMENT. AS IT WAS STATED THE LABEL WAS CHIPPING OFF. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448430 EQT HOLDER, CAMERA, SURGICAL FXR MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown