BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 1629431 · Received March 10, 2010

    Report

    Report Number
    3007417753-2010-00001
    Event Type
    Other
    Date Received
    March 10, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 11, 2010
    Manufacturer
    MAQUET SUZHOU COMPANY LTD
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET SERVICE REP. VISITED THE HOSPITAL TO EVALUATE THE DEVICE. THE TECHNICIAN FOUND THAT THE END CAP WHICH FELL HAD BEEN DAMAGED AND THAT THE ARM IT WAS INSTALLED UPON EXHIBITED EVIDENCE OF A COLLISION WITH ANOTHER OBJECT. THE SERVICE REP REPORTED THAT NEW THIRD PARTY EQUIPMENT HAD BEEN ADDED TO THE HOSPITAL'S OPERATING ROOMS AFTER THE INITIAL INSTALLATION OF THE MODUTEC UNITS AND THAT THIS EQUIPMENT FORCED AN OPERATOR TO MOVE THE ARMS INTO THE PATHS OF ONE ANOTHER OR OTHER EQUIPMENT DURING USE. BECAUSE MAQUET SERVICE FOUND MULTIPLE END CAPS AT THIS HOSPITAL THAT WERE LOOSE, DAMAGED OR MISSING, AN INTERNAL INVESTIGATION WAS UNDERTAKEN. AFTER REVIEWING THE DEVICE HISTORY AND EVALUATING EXISTING INVENTORIES, MAQUET WAS UNABLE TO IDENTIFY ANY DESIGN ISSUE WHICH COULD ACCOUNT FOR THE END CAP FALLING. BASED UPON THE EVIDENCE AT HAND, MAQUET BELIEVES THAT END CAP THAT FELL, BROKE LOOSE AFTER A COLLISION WITH ANOTHER DEVICE IN THE HOSPITAL'S OPERATING ROOM. MAQUET SERVICE REPLACED ALL THE DAMAGED END CAPS AT THIS HOSPITAL AND HAS RESET THE MODUTEC LIMIT STOPS TO PREVENT ANY FURTHER COLLISIONS. MAQUET IS IN THE PROCESS OF ARRANGING AN IN SERVICE VISIT TO EDUCATE HOSPITAL STAFF IN THE PROPER USE OF THE MODUTEC EQUIPMENT. MAQUET INC SUBMITS THIS REPORT ON BEHALF OF (B)(4) WHO PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. MAQUET INC., WILL SUBMIT AN ADDITIONAL REPORT AS THE US IMPORTER. (B)(4).

    Description of Event or Problem · 1

    HOSPITAL SERVICE CONTACTED MAQUET INC TO REPORT THAT A MODUTEC END CAP FELL BETWEEN PROCEDURES. IT WAS LATER REPORTED THAT THIS END CAP FELL ONTO A PT POST-PROCEDURE. THE HOSPITAL DID NOT REPORT ANY INJURY OR DEATH TO THE PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET BYX MAQUET SUZHOU COMPANY LTD MODUTEC

    Patients

    Seq Age Sex Outcome Treatment
    1