BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASIGHT

    MDR report key: 18603053 · Received January 29, 2024

    Report

    Report Number
    3008363989-2024-00006
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    January 4, 2024
    Report Date
    April 10, 2024
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    UDI-DI
    00845225012878
    PMA / PMN Number
    K190078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. BLOCKS A2-A5: 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: AT THE CUSTOMER SITE, A FIELD SERVICE ENGINEER REPLACED THE CRACKED INTRASIGHT SYSTEM TOUCHSCREEN MONITOR. BLOCKS H7 & H9: 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

    BLOCKS B1/B5/H1: BASED ON THE RETURNED PRODUCT EVALUATION, THIS IS NO LONGER REPORTABLE FOR A PRODUCT PROBLEM. THERE IS NO POTENTIAL FOR HARM FOR CRACKS, UNLESS A SHARP EDGE IS CONFIRMED. BLOCKS D9/G3: THE INTRASIGHT TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. BLOCK H3: VISUAL INSPECTION FOUND A CRACKED SCREEN, BUT NO SHARP EDGES WERE NOTED AS DETERMINED BY A GLOVE TEST. BLOCK H6: MEDICAL DEVICE PROBLEM CODE CORRECTED FROM 4013 (SHARP EDGES) TO 1135 (CRACK) BASED ON THE RETURNED PRODUCT EVALUATION. THE COMPLAINT CODES LISTED IN THE INITIAL MDR REMAIN ACCEPTABLE (3243- INVESTIGATION FINDINGS AND 61- INVESTIGATION CONCLUSION). 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.

    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.

    Description of Event or Problem · 0

    THIS PRODUCT PROBLEM IS NO LONGER REPORTABLE BECAUSE NO SHARP EDGES WERE OBSERVED DURING THE RETURNED PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538232 INTRASIGHT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VOLCANO CORPORATION 797403 1397975 00845225012878

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown