BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLX 3000

    MDR report key: 17661809 · Received August 31, 2023

    Report

    Report Number
    9710055-2023-00609
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Report Date
    August 31, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 3000. IT WAS STATED THE PAINT WAS CHIPPING FROM THE ARMS OF THE SURGICAL LIGHT ASSEMBLY, LABEL WAS TORN AND THE CONNECTION OF THE SUSPENSION ARMS WAS LOOSE AND GRINDING CAUSING THE PAINT TO COME OFF AND RISK OF THE DEVICE FALLING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS UNEVEN AND LOOSE CONNECTION OF THE ARMS COULD LEAD TO THE DETACHMENT OF THE ARM AND CONSEQUENTLY TO SERIOUS INJURY. MOREOVER ANY PARTICLES 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 TORN LABEL, PAINT PEELING AND LOOSE SUSPENSION ARM CONNECTION WHICH COULD BE CONSIDERED AS TECHNICAL DEFICIENCIES AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, IT WAS CONFIRMED THAT IN THE LAST 5 YEARS, REGISTERED FOR THE ISSUE OF TORN LABEL, PAINT PEELING AND LOOSE SUSPENSION ARM CONNECTION ON HLX SURGICAL LIGHTS, 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 OF PAINT PEELING, TORN LABEL AND LOOSE SUSPENSION ARM CONNECTION ARE 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 TORN LABEL, THE USER MANUAL MENTIONS INSTRUCTIONS CONCERNING CLEANING AND DISINFECTION, RECOMMENDED AND PROHIBITED PRODUCTS. (HLX2000 IFU 56351039/E, PAGES 19-20) ADDITIONALLY, MANUFACTURER ESTABLISHED THAT WHILE OBSERVING THE PICTURES TAKEN BY THE SSU, WE DO NOT RECOGNIZE THE MODEL OF THE SUSPENSION, IT IS NOT A PRODUCT FROM MAQUET/GETINGE. THE LIGHTHEAD AND THE SPRING ARM HAVE BEEN ASSEMBLED ON THIS OLD SUSPENSION OF THE BRAND GS HOWEVER, WE ARE UNABLE TO DETERMINATE THE PROBABLE ROOT CAUSES FOR PAINT PEELING AND SUSPENSION ARM GRINDING, RISK OF ARM'S DETACHMENT, DUE TO FACT THAT THE SUSPENSION AND THE ANCHORAGE ARE NOT A PRODUCTS FROM MAQUET. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATIONS HAD BEEN FOLLOWED, THE INCIDENT COULD HAVE BEEN AVOIDED. 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), 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 3000. IT WAS STATED THE PAINT WAS CHIPPING FROM THE ARMS, LABEL WAS TORN AND THE CONNECTION OF THE SUSPENSION ARMS WAS LOOSE AND GRINDING CAUSING THE PAINT TO COME OFF AND RISK OF THE DEVICE FALLING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS UNEVEN AND LOOSE CONNECTION OF THE ARMS COULD LEAD TO THE DETACHMENT OF THE ARM AND CONSEQUENTLY TO SERIOUS INJURY. MOREOVER ANY PARTICLES 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
    1438301 HLX 3000 LAMP, SURGICAL FTD MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown