BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESAOTE

    MDR report key: 3663246 · Received December 20, 2013

    Report

    Report Number
    9611125-2013-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    September 8, 2013
    Report Date
    December 20, 2013
    Manufacturer
    ESAOTE S.P.A.
    Product Code
    IYN
    PMA / PMN Number
    K121384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ESAOTE HAS CONDUCTED AN INVESTIGATION AND CONFIRMED ON (B)(4) 2013 THAT THE SURFACE TEMPERATURE OF THE PA230E TO BE 60 DEGREES C IN STILL AIR CONDITIONS. THE UNIT INVOLVED IN THE REPORT HAS BEEN EVALUATED AND RESULTS INDICATE THE DEVICE IS PERFORMING AT THE UPPER LIMIT OF SPECIFICATIONS. IF THE UNITS AT THE UPPER LIMIT OF SPECIFICATIONS INCREASE THE POWER TO THE ALLOWED MAXIMUM, IN COMBINATION WITH SPECIFIC SETTING TO SCAN DIFFICULT TO IMAGE PATIENTS, PROBES AT THE UPPER LIMIT OF SPECIFICATIONS MAY EXCEED TEMPERATURE LIMITS AT THE SURFACE. THIS RESULTS IN THE POSSIBILITY OF A PATIENT EXPERIENCING SOME DISCOMFORT. THERE ARE MORE THAN (B)(4) TRANSDUCERS IN THE FIELD OVER A PERIOD OF (B)(4) AND ESAOTE HAS NOT RECEIVED ANY SIMILAR COMPLAINTS. IN ORDER TO INCREASE THE SAFETY MARGIN TO ENSURE THAT THE TEMPERATURE LIMIT WILL NOT BE EXCEEDED BY TRANSDUCERS AT THE UPPER LIMIT OF SPECIFICATIONS, ESAOTE WILL BE ISSUING A NON-MANDATORY SOFTWARE UPGRADE WITHIN (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2013, WE WERE NOTIFIED BY A REMANUFACTURER, THAT THEY RECEIVED A COMPLAINT OF AN ESAOTE CARDIAC PROBE, PA230E HEATING EXCESSIVELY DURING A SCAN OF A DIFFICULT TO IMAGE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT OR USER. THE REMANUFACTURER MEASURED THE SURFACE TEMPERATURE OF THE PROBE AND INDICATED THAT IT WAS ABOVE THE SAFETY STANDARD'S LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670893 ESAOTE ULTRASONIC DIAGNOSTIC TRANSDUCER IYN ESAOTE S.P.A. PA230E

    Patients

    Seq Age Sex Outcome Treatment
    1