BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV 25

    MDR report key: 1912435 · Received November 10, 2010

    Report

    Report Number
    3003768277-2010-00292
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 11, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K921255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS): THE INVESTIGATION FOUND A DEFECTIVE STAND TROLLEY CABLE. THE STAND TROLLEY CABLE CONNECTS THE STAND AND THE C-ARM. THE CABLE MAY BECOME DEFECTIVE IF THE STAND OR C-ARM ARE NOT HANDLED WITH CARE. IT SEEMS ON THIS SYSTEM THE DEFECTIVE CABLE WAS DUE TO NORMAL WEAR AND TEAR. FROM TRENDING IT IS FOUND THAT THE CABLE IS A RELIABLE PART WITH NO INCREASED FAILURE RATE. ALSO, THIS IS AN OLD SYSTEM THAT WAS OUT OF SERVICE. REPLACEMENT OF THE CABLE RESTORES FULL SYSTEM FUNCTIONALITY. WHEN A SYSTEM INTERMITTENTLY FAILS DUE TO THIS DEFECTIVE PART THE SYSTEM RESTARTS WITHIN A MINUTE. ON SYSTEM STARTUP THE FUNCTIONALITY IS CHECKED TO PREVENT ANY ABNORMAL SYSTEM BEHAVIOR CAUSING PROBLEMS DURING OPERATION. SINCE THIS IS A MOBILE SYSTEM IT CAN BE EASILY REPLACED BY ANOTHER. THEREFORE, THE RISK TO PATIENT HEALTH IS ESTIMATED AS ACCEPTABLE. ((B)(4). ).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THIS X-RAY SYSTEM WAS SHUTTING DOWN DURING OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV 25 IZL (MOBILE X-RAY SYSTEM) IZL PHILIPS MEDICAL SYSTEMS 71807 NA

    Patients

    Seq Age Sex Outcome Treatment
    1