BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA STANDOP

    MDR report key: 7471974 · Received April 30, 2018

    Report

    Report Number
    9710055-2018-00023
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 4, 2018
    Report Date
    May 29, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K130513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION # E2018005. (B)(4). MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT VOLISTA STANDOP DEVICE. AS IT WAS STATED, THE BUMPER FELL OFF DURING SURGERY. THERE WAS NO INJURY REPORTED. THERE ARE NO KNOWN CLINICAL CONSEQUENCES FOR THE PATIENT. BUMPER IS USED TO COVER THE BOTTOM OF THE MAIN TUBE AND ACCESS TO CABLES INSIDE THE SURGICAL LIGHT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN EVENT OCCURRED THE DEVICE WAS USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. AS PER PERFORMED TESTS THE ROOT CAUSE OF FALLING BUMPER IS LIKELY CAUSED BY SEVERAL VIOLENT COLLISIONS WITH THE CUPOLAS, THIS HAPPENS WHILE THE USER IS NOT BEING CAREFUL WITH MOVING THE DEVICE ARMS AND LIGHTS. THE PRODUCT VOLISTA STANDOP USER MANUAL 01761EN ED. 08 ON PAGE 12 INCLUDES AN INFORMATION THAT THE SAFETY AND INTEGRITY OF THE OPERATION OF THE PRODUCT ARE GUARANTEED ONLY IF ALL INSPECTION, MAINTENANCE AND REPAIR OPERATIONS ARE PERFORMED BY A MAQUET ENGINEER OR AN AUTHORIZED TECHNICIAN. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE 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

    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 INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER 2018-59059.

    Description of Event or Problem · 0

    ON (B)(4) 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- VOLISTA. AS IT WAS STATED, THE BUMPER FELL OFF DURING SURGERY. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316891 VOLISTA STANDOP LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1