BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASIGHT

    MDR report key: 20286719 · Received September 23, 2024

    Report

    Report Number
    3008363989-2024-00053
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    September 9, 2024
    Report Date
    February 14, 2025
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    UDI-DI
    00845225012878
    PMA / PMN Number
    K190078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G: SITE NAME AND ADDRESS CORRECTED FROM VOLCANO CORPORATION LOCATION TO VOLCARICA S.R.L LOCATION.

    Additional Manufacturer Narrative · 0

    BLOCKS B1/B5/H2: BASED ON NEW INFORMATION RECEIVED, THIS HAS BEEN DETERMINED AS NO LONGER REPORTABLE. THE FIELD SERVICE ENGINEER WHO WAS ONSITE TO PERFORM THE TOUCHSCREEN REPLACEMENT, CONFIRMED THAT THE BROKEN SCREEN WAS FOR AN IPAD (NOT A PHILIPS COMPONENT). NO ISSUES WERE FOUND WITH THE TOUCHSCREEN MONITOR; THEREFORE, THE TOUCHSCREEN REPLACEMENT WAS RETURNED TO STOCK UNUSED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. BLOCKS A2-A6: NO PATIENT INVOLVEMENT. BLOCKS B6 & B7: NO PATIENT INVOLVEMENT. BLOCK C: NOT APPLICABLE. BLOCK D4: EXPIRATION DATE IS NOT APPLICABLE. BLOCKS D6, D7, & D10: NOT APPLICABLE; NO PATIENT INVOLVEMENT. BLOCKS H3 & H6: THE INTRASIGHT TOUCHSCREEN MONITOR WAS NOT RETURNED FOR EVALUATION, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BLOCKS H7, H9, & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    SECTION H5: LABELED FOR SINGLE USE WAS CORRECTED FROM YES TO NO.

    Description of Event or Problem · 0

    THIS PRODUCT PROBLEM IS NO LONGER REPORTABLE BECAUSE THE CRACKED TOUCHSCREEN WITH SHARP EDGES WAS NOT PART OF THE INTRASIGHT SYSTEM; RATHER IT WAS A BROKEN IPAD FROM A DIFFERENT MANUFACTURER. THEREFORE, THERE IS NO POTENTIAL FOR HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRASIGHT SYSTEM TOUCHSCREEN MONITOR WAS CRACKED WITH SHARP EDGES OBSERVED. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED IN AN ABUNDANCE OF CAUTION BECAUSE THE TOUCHSCREEN MONITOR HAS SHARP EDGES THAT CAN RESULT IN A POTENTIAL FOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066898 INTRASIGHT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VOLCANO CORPORATION 797403 00845225012878

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown