BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLX 2004

    MDR report key: 12974066 · Received December 10, 2021

    Report

    Report Number
    9710055-2021-00371
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Report Date
    March 1, 2022
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF B5 DESCRIBE EVEN OR PROBLEM, D1 BRAND NAME AND D4 VERSION OF MODEL # DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVEN OR PROBLEM: ON 16TH NOVEMBER, 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 3000. AT IT WAS STATED THE LENSES OF LIGHT WERE CRACKED AND THE PARTICLES WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DEVICE PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. CORRECTED B5 DESCRIBE EVEN OR PROBLEM: ON 16TH NOVEMBER, 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 2004. AT IT WAS STATED THE LENSES OF LIGHT WERE CRACKED AND THE PARTICLES WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DEVICE PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. PREVIOUS D1 BRAND NAME: HLX 3000. CORRECTED D1 BRAND NAME: HLX 2004. PREVIOUS D4 VERSION OF MODEL #: HLX 3000. CORRECTED D4 VERSION OF MODEL #: HM56067740. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 2004. AT IT WAS STATED THE LENSES OF THE SURGICAL LIGHT WERE CRACKED AND THE PARTICLES WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DEVICE 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 THE CRACKED LENSES, WHICH CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION INDICATES THAT UPON THE ISSUE DETECTION, THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. UNFORTUNATELY, MAQUET DID NOT RECEIVE ENOUGH INFORMATION TO CONDUCT THE TECHNICAL INVESTIGATION. BASED ON THE REVIEW BY THE SUBJECT MATTER EXPERT AT MANUFACTURER, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE AND THEREFORE THE FACTORY INVESTIGATION REPORT CANNOT BE PERFORMED. IN CASE OF NEW RELEVANT INFORMATION, THE CASE WILL BE RECONSIDERED. HOWEVER, AS STATED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S, THE MOST PROBABLE CAUSES IN THIS CASE ARE COLLISIONS. WHAT COULD HAVE ALSO CONTRIBUTED TO THE PROBLEM IS THE AGE OF THE AFFECTED DEVICE. REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO INVESTIGATED ISSUE, REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. 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

    THE NEW OBTAINED INFORMATION IS MANUFACTURING DATE: AUG-1993. ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 16TH NOVEMBER, 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 2004. AT IT WAS STATED THE LENSES OF LIGHT WERE CRACKED AND THE PARTICLES WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DEVICE PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6), 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 3000. AT IT WAS STATED THE LENSES OF LIGHT WERE CRACKED AND THE PARTICLES WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DEVICE PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877939 HLX 2004 LAMP, SURGICAL FTD MAQUET SAS HM56067740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown