BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASIGHT

    MDR report key: 13904596 · Received March 25, 2022

    Report

    Report Number
    3008363989-2022-00022
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Date of Event
    March 4, 2022
    Report Date
    July 26, 2022
    Manufacturer
    PHILIPS VOLCANO
    Product Code
    IYO
    UDI-DI
    00845225012878
    PMA / PMN Number
    K190078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. NO PATIENT INVOLVEMENT. LOT# AND EXPIRATION DATE ARE NOT APPLICABLE. NOT APPLICABLE; NO PATIENT INVOLVEMENT. AT THE CUSTOMER SITE, A FIELD SERVICE ENGINEER REPLACED THE CRACKED INTRASIGHT SYSTEM'S TOUCHSCREEN MONITOR AND VERIFIED THAT IT IS WORKING GOOD TO OEM SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    BASED ON THE RETURNED PRODUCT EVALUATION, THIS IS NO LONGER REPORTABLE FOR A PRODUCT PROBLEM/MALFUNCTION. BLOCKS D9/G3: THE INTRASIGHT TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. BLOCK H3: VISUAL INSPECTION FOUND A CRACKED SCREEN WITH MISSING MATERIAL, 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 (10- TYPE OF INVESTIGATION, 3252- INVESTIGATION FINDINGS, AND 61- INVESTIGATION CONCLUSION). THE PROBABLE CAUSE IS LIKELY DAMAGED FROM USE. THE DEVICE INTEGRITY CAN BE AFFECTED BY EXTERNAL FACTORS SUCH AS DEVICE MANIPULATION, ITS IMPACT, AND APPLIED PRESSURE ASSOCIATED WITH USE AND HANDLING. 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 MANUFACTURER'S SYSTEM'S TOUCHSCREEN MONITOR WAS CRACKED IN TWO CORNERS 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 WAS CRACKED IN TWO CORNERS WITH 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
    1053662 INTRASIGHT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PHILIPS VOLCANO 797403 00845225012878

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown