BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA

    MDR report key: 20892351 · Received December 10, 2024

    Report

    Report Number
    9710055-2024-0000625
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 10, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    UDI-DI
    03700712420642
    PMA / PMN Number
    K130513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ VOLISTA ACCESS II. AS IT WAS STATED, THE KEYPAD WAS NOT WORKING AS ITS UPPER TOUCH GLASS SEAL WAS REMOVED FROM PCB. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE, THE FRONT OF THE KEYPAD DETACHED FROM THE PCB. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION IN CASE OF REOCCURRENCE. THE DEVICE HAS BEEN REPAIRED BY REPLACEMENT OF VCS2-400/600- LIGHT HEAD KEYPAD W/OUT TK (ARD368876555) AND RETURNED TO USE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS NOT KNOWN IF THE CLAIMED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ACCORDING TO THE ANALYSIS BY SUBJECT MATTER EXPERT: THE VCSII HEADLIGHT¿S KEYPAD FOIL DETACHED AND DROPPED. THE ROOT CAUSE OF THE FRONT PANEL DETACHMENT IN THE CAPACITIVE KEYBOARD TO THE PCB LIES IN THE ADHESIVE CHOICE IMPLEMENTED DURING THE PRODUCT DESIGN STAGE. A DESIGN CHANGE (ECR-241203) HAS BEEN INITIATED IN ORDER TO IMPROVE THE KEYPAD ADHERENCE TO THE PCB. THIS ECR IS NOT IMPLEMENTED YET AND IS PLANNED FOR SEP-2025. THIS TOPIC REMAINS THE SOURCE OF VERY FEW INCIDENTS, DESPITE EVERYTHING. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1B EVENT SITE NAME: (B)(6).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(6).

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ VOLISTA ACCESS II. AS IT WAS STATED, THE KEYPAD WAS NOT WORKING AS ITS UPPER TOUCH GLASS SEAL WAS REMOVED FROM PCB. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE, THE FRONT OF THE KEYPAD DETACHED FROM THE PCB. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION IN CASE OF REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536566 VOLISTA LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDVCS209031A 03700712420642

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown