BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMALIX

    MDR report key: 6821019 · Received August 25, 2017

    Report

    Report Number
    9710055-2017-00054
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 26, 2017
    Report Date
    January 26, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET SAS BECAME AWARE OF AN INCIDENT WITH SURGICAL LIGHT PRISMALIX DEVICE. AS IT WAS STATED BY THE CUSTOMER, THE SPRING ARM TENSION WAS OUT OF ADJUSTMENT AND THE PAINT ON THE TOP COVER OF THE LIGHT HEAD WAS FLAKING OFF. THERE WAS NO PATIENT INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT-HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. THE CIRCUMSTANCES OF THE EVENT ARE UNKNOWN. DURING THE INVESTIGATION IT WAS FOUND THAT THERE IS NO APPARENT TREND WITH THE ISSUE AT HAND AND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE. USER MANUAL FOR PRISMALIX DEVICE (0113103) INCLUDES AN INFORMATION HOW TO PROPERLY CLEAN AND DISINFECT THE SURGICAL LIGHT. THERE ARE ALSO PRODUCTS RECOMMENDED TO USE FOR CLEANING AND DISINFECTION PROCESS. HOWEVER, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS STAGNATION OF AGGRESSIVE DISINFECTANT AND DETERGENT PRODUCTS DUE TO AN INAPPROPRIATE CLEANING PROTOCOL. MAQUET SAS RECOMMENDS TO RESPECT THE CLEANING PROTOCOL AND AVOID PROLONGED EXPOSURE TO DETERGENTS AND DISINFECTANT SOLUTIONS, HIGH CONCENTRATIONS AND PROHIBITED PRODUCTS TO PREVENT ANY OTHER SIMILAR INCIDENT. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED.

    Additional Manufacturer Narrative · 1

    THE ISSUE WILL BE INVESTIGATED BY THE MANUFACTURING SITE.

    Description of Event or Problem · 1

    MFR REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF THE DEVICES- PRISMALIX. AS IT WAS STATED BY THE CUSTOMER THE SPRING ARM TENSION WAS OUT OF ADJUSTMENT AND THE PAINT ON THE TOP COVER OF THE LIGHT HEAD WAS FLAKING OFF. WE DID NOT ESTABLISH YET WHEN WAS THE ISSUE DISCOVERED HOWEVER WE DECIDED TO REPORT IT IN ABUNDANCE OF CAUTION. MFR REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601265 PRISMALIX LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1