BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER, S8 3T MICRO TEE

    MDR report key: 3979015 · Received June 27, 2014

    Report

    Report Number
    3019216-2014-00013
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    May 30, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYO
    PMA / PMN Number
    K030455,
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ; THOUGH REQUESTED, THE S8 3T HAS NOT BEEN RECEIVED FOR FURTHER EVALUATION. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE DEVICE IS RETURNED AND EVALUATION IS COMPLETED. ADDITIONAL PMA/510(K) #: K034003

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE S8- 3T TRANSDUCER WAS EXHIBITING POOR IMAGE QUALITY. THE PROCEDURE WAS COMPLETED WITH THE SAME TRANSDUCER. THE ISSUE DID NOT AFFECT PATIENT OUTCOME. NO PATIENT OR USER HAS BEEN HARMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378373 TRANSDUCER, S8 3T MICRO TEE IYO IYN ITX IYO PHILIPS ULTRASOUND, INC 989605420181

    Patients

    Seq Age Sex Outcome Treatment
    1