BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASIGHT MOBILE

    MDR report key: 15396929 · Received September 9, 2022

    Report

    Report Number
    3008363989-2022-00061
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 24, 2022
    Report Date
    September 27, 2022
    Manufacturer
    PHILIPS VOLCANO
    Product Code
    IYO
    UDI-DI
    00845225012915
    PMA / PMN Number
    K203719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. AT THE CUSTOMER SITE, A FIELD SERVICE ENGINEER REPLACED THE CRACKED INTRASIGHT MOBILE SYSTEM''S TOUCHSCREEN MONITOR. 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

    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. THE INTRASIGHT MOBILE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND A CRACKED SCREEN WITH MISSING MATERIAL, BUT NO SHARP EDGES WERE NOTED AS DETERMINED BY A GLOVE TEST. 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 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 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
    1138969 INTRASIGHT MOBILE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PHILIPS VOLCANO 797415 00845225012915

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown