BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED 700

    MDR report key: 16983337 · Received May 23, 2023

    Report

    Report Number
    9710055-2023-00389
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 15, 2023
    Report Date
    May 23, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATIONS DUE TO THE MISSING SPRING ARM¿S DUST COVER, WHICH CONTRIBUTED TO THE EVENT. THE AVAILABLE INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. THE REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO THE INVESTIGATED ISSUE REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THESE PARTICULAR MALFUNCTIONS OCCURRED. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO OF THE DETACHMENT OF SPRING ARM¿S COVERS AND CAPS IS MODERATE. AS STATED BY THE SUBJECT MATTER EXPERT THE METAL SPRING ARM¿S METAL COVER (DUST COVER) CAME OUT AND CAN FELL OFF THE DEVICE. THE PERFORMED INVESTIGATION ALLOWED TO DISTINGUISH POSSIBLE ROOT CAUSES FOR THIS MALFUNCTION: ¿ NON¿CONFORMITY OF THE METAL COVERS ASSEMBLY ¿ DEGRADATION OF THE METAL COVERS ¿ IMPROPER USE (COLLISION WITH ANOTHER DEVICE) MAQUET SAS ANALYSIS SHOWS THAT THE METAL STRIP COMES OUT OF THE COVERS WHEN IT IS NOT CLIPPED PROPERLY. IN THE SCOPE OF OUR CONTINUOUS IMPROVEMENT POLICY, MAQUET SAS INITIATED A MODIFICATION FILE TO INCLUDE THIS DUST COVER FITTING PROCEDURE IN THE TECHNICAL DOCUMENTATIONS WITH ALL SPRING ARMS. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GETINGE 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 15TH MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE DUST COVER AT THE BOTTOM OF THE SPRING ARM THAT MOVES THE LAMP UP AND DOWN HAS COME OFF. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256891 POWERLED 700 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568370902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown