BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOUND F75 ULTRASOUND SCANNER

    MDR report key: 3963714 · Received July 16, 2014

    Report

    Report Number
    9610865-2014-00001
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 26, 2014
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD
    Product Code
    GXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE: PROSOUND F75 ULTRASOUND SCANNER (K123828) - POSSIBILITY THAT A GEL THREADLOCKER COATING HAS NOT BEEN ADDED TO THE SCREWS WHICH HOLD THE ARM TOGETHER, RESULTING IN INSTABILITY OR LOOSE MONITOR ARM. TO DATE THIS ISSUE HAS NOT AFFECTED ANY PATIENTS OR CAUSED ANY PHYSICAL HARM. REVIEW OF ALL AFFECTED MANUFACTURING SERIAL NUMBERS SOLD IN THE UNITED STATES FOR SERVICE AND COMPLAINT IDENTIFIED ONE COMPLAINT OF "LOOSE MONITOR ARM". THIS SERVICE/COMPLAINT RECORD NUMBER: (B)(4) IS DATED 12/10/2013. THE SERVICE PERSON TIGHTENED THE LOOSE SCREWS IN THE MONITOR ARM AND CORRECTED THE PROBLEM WITHOUT FURTHER ISSUE. THERE IS NO COMPLAINT OF INJURY, ADVERSE EVENT, OR REPEATED COMPLAINTS OF LOOSENED MONITOR ARM ASSOCIATED WITH THIS CUSTOMER SINCE SERVICING THE DEVICE IN DECEMBER. THIS REPORT IS TO NOTIFY THE FDA OF AN ASSEMBLY ISSUE AND CORRECTIVE ACTION TO REPLACE ALL AFFECTED SERIAL NUMBERS WITH A NEW MONITOR ARM. AFFECTED SERIAL NUMBERS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415514 PROSOUND F75 ULTRASOUND SCANNER PROSOUND F75 GXX HITACHI ALOKA MEDICAL, LTD F75

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention