BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2008-00017

    MDR report key: 1285386 · Received October 23, 2008

    Report

    Report Number
    9710055-2008-00017
    Event Type
    Other
    Date Received
    October 23, 2008
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET REP VISITED THE HOSP AND EVALUATED THE DEVICE. THE HOSPITAL'S STAFF REPORTED THAT THE BIOMED HAD SWAPPED TWO XTEN CUPOLAS IN OR #10 AND OR #9 IN AN ATTEMPT TO IMPROVE THE VIDEO CAMERA IMAGE QUALITY PRIOR TO THIS INCIDENT. DURING THE EXCHANGE, THE RING THAT HOLDS THE SAFETY SEGMENT IN PLACE WAS INSTALLED BACKWARDS. THIS PREVENTED THE SEGMENT FROM SEATING PROPERLY, ALLOWING THE CUPOLA TO RELEASE. MAQUET SVC REP REPAIRED THE SURGICAL LIGHT, AND VERIFIED ALL COMPONENTS WERE INTALLED PROPERLY. THE CUSTOMER WAS MADE AWARE OF THE ROOT CAUSE AND WAS ADVISED TO CONTACT MAQUET IF SVC WAS REQUIRED IN FUTURE. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FSY

    Patients

    Seq Age Sex Outcome Treatment
    1