BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMALIX W/ ENERGIX

    MDR report key: 3420976 · Received September 24, 2013

    Report

    Report Number
    9710055-2013-00034
    Event Type
    Other
    Date Received
    September 24, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K040015
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) INSPECTED THE DEVICE AND FOUND THAT THE RETAINING CLIP (A.K.A.CIRCLIP) USED TO SECURE THE LIGHTING SYSTEM TO ITS DOWN TUBE MOUNT, HAD BEEN INCORRECTLY INSTALLED. THE CIRCLIP WAS BENT AND OUT OF ITS GROOVE. THE MAQUET INVESTIGATION REVEALED THAT THE ARM HAD BEEN DISMANTLED IN (B)(4) 2013 DURING MAINTENANCE DONE BY A THIRD PARTY MAINTENANCE PROVIDER. MAQUET DETERMINED THAT THE TECHNICIAN INCORRECTLY POSITIONED THE CIRCLIP AT THE END OF THIS MAINTENANCE WHICH LED TO THE REPORTED EVENT. THE MAQUET FST REPAIRED THE DEVICE, INSTALLING A NEW CIRCLIP AND WASHERS, AND RETURNED THE UNIT TO SERVICE. THE PRISMALIX SERIES INSTALLATION MANUAL INCLUDES ALL NECESSARY INSTRUCTIONS TO INSTALL THE ARM TO THE CEILING TUBE. (B)(4). MAQUET MEDICAL SYSTEM USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MAQUET THAT DURING A SURGICAL INTERVENTION, WHILE A NURSE WAS ATTEMPTING TO REPOSITION A CUPOLA, THE SURGICAL LIGHT DETACHED FROM THE CEILING MOUNTING TUBE. THE FALLING COMPONENTS STRUCK THE PATIENT ON HIS RIGHT SIDE FROM THE FOREARM TO THE CHIN. THE PATIENT WAS SENT FOR AN EXAMINATION. THE HOSPITAL HAS NOT PROVIDED ANY DETAILS WITH RESPECT TO THE PATIENT RESULTANT FROM THIS EVENT. THE SURGEON WAS STRUCK ON HIS HEAD, CONCUSSED AND REQUIRED TWO STITCHES. (B)(4). REF. IMP REPORT #3008355164-2013-00232.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483068 PRISMALIX W/ ENERGIX FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1