BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT, SURGICAL, CEILING MOUNTED

    MDR report key: 8363779 · Received February 22, 2019

    Report

    Report Number
    9710055-2019-00045
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Report Date
    March 4, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ISSUE IS BEING INVESTIGATED BY THE MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICE ¿ XS SINGLE FLAT SCREEN HOLDER. PROVIDED ALLEGATION WAS INDICATING HANDLE BEING MISSING, WHICH COULD BEEN EITHER DISASSEMBLED BY THE USER OR FALLING OFF THE DEVICE. UNFORTUNATELY, DESPITE OUR BEST EFFORTS TO OBTAIN ADDITIONAL AND MORE DETAILED INFORMATION, NO MORE DATA WAS PROVIDED. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING INTO THE STERILE FIELD MIGHT BE A SOURCE OF CONTAMINATION. THE DEVICE WAS REPAIRED BY COMPANY REPRESENTATIVE BY REPLACING THE FAULTY COMPONENT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. NONE OF THE PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. OUR INVESTIGATION FINDS THAT A DAMAGED MONITOR HANDLE WOULD BE MOST LIKELY CAUSED BY LACK OF MAINTENANCE OR IMPROPER HANDLING OF THE DEVICE. WE BELIEVE THAT 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 WE 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) 2019, MAQUET SAS BECAME AWARE OF AN ISSUE WITH ONE OF THE DEVICES- FLAT SCREEN HOLDER XS. AS IT WAS STATED, HANDLE AND HANDLE ADAPTER WERE MISSING FROM THE DEVICE. THERE WAS NO INJURY REPORTED AND THE CIRCUMSTANCES OF THE ISSUE ARE UNKNOWN. HOWEVER CONSIDERING THE WORSE CASE SCENARIO THE MISSING PARTICLES COULD DETACH FROM THE DEVICE AND FALL OFF INTO THE STERILE FIELD, THEREFORE WE DECIDED TO REPORT THIS ISSUE IN ABUNDANCE OF CAUTION AS IT MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: 194675.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: 194675.

    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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157647 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other