BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA ACCESS

    MDR report key: 8582361 · Received May 6, 2019

    Report

    Report Number
    9710055-2019-00164
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 6, 2019
    Report Date
    March 17, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. INFORMATION ABOUT THE CUSTOMER INVOLVED WAS RECEIVED AND IS INCLUDED IN E SECTION.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH VOLISTA SURGICAL LIGHT. AS IT WAS ALLEGED BY THE USER, THE LIGHT HEAD PRODUCED AN ENORMOUS HEAT. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS HEAT MAY LEAD TO AN INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT. THE ISSUE WAS INVESTIGATED BY A SUBJECT MATTER EXPERT. IT WAS FOUND THAT THE CUSTOMER FEEDBACK RECEIVED WAS SUBJECTIVE AND COULD NOT BE REPRODUCED AND OBJECTIVELY MEASURED. WE CONCLUDED THAT THE ISSUE COULD BE RELATED TO SUBJECTIVE FEELING OF THE USER OR ISSUES WITH AIR CONDITIONING OF THE AFFECTED ROOM. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN THE COMPLAINTS WE 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 ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074 EXEMPTION # E2018005. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON:(B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER 2019-63202.

    Description of Event or Problem · 0

    ON (B)(6) 2019 MAQUET SAS BECAME AWARE OF AN ISSUE WITH VOLISTA SURGICAL LIGHT. AS IT WAS STATED, LIGHT HEAD PRODUCED AN ENORMOUS HEAT, WHICH MAY LEAD TO ADVERSE OUTCOME. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS HEAT MAY LEAD TO AN INJURY. MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377814 VOLISTA ACCESS LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1