BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE 6TC TEE PROBE

    MDR report key: 3179592 · Received June 13, 2013

    Report

    Report Number
    9610482-2013-00002
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 16, 2013
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K121063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. PT ID AND WEIGHT WERE NOT PROVIDED BY THE HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INJURY OCCURRED DURING A TEE/TEO EXAM. THE CLINICIAN WAS PERFORMING A TEE STUDY AND WHEN THE PROBE WAS REMOVED, AN ESOPHAGEAL TEAR OCCURRED WHICH RESULTED IN A HIGHER LEVEL OF CARE. THE PT WAS REPORTEDLY AIR LIFTED TO ANOTHER HOSP AND UNDERWENT EMERGENCY REPAIR OF THE TEAR. THE OUTCOME OF THE PT IS UNK AND THE HOSP DID NOT INDICATE ANY DEVICE MALFUNCTION WAS INVOLVED. THE RISK MGR STATED THEY HAVE NO FURTHER INFO REGARDING THE HEALTH STATUS OF THE PT. ADDITIONALLY, THE FACILITY HAS COMPLETED A ROOT CAUSE ASSESSMENT OF THE INCIDENT AND HAS CONCLUDED THAT NEITHER THE PROBE NOR THE SYS MALFUNCTIONED TO CAUSE THE ESOPHAGEAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268993 GE HEALTHCARE 6TC TEE PROBE TRANS-ESOPHAGEAL ECHOCARDIOGRAPHY PROBE IYN GE VINGMED ULTRASOUND AS KN100104

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R