BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IC9-RS

    MDR report key: 18620447 · Received February 1, 2024

    Report

    Report Number
    9710090-2024-00003
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Report Date
    March 12, 2024
    Manufacturer
    GE ULTRASOUND KOREA, LTD.
    Product Code
    ITX
    PMA / PMN Number
    K213642
    Removal / Correction Number
    8020021-12/29/23-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS KOREA - 9, SUNHWAN-RO 214BEON-GIL JUNGWON-GU KOREA, REPUBLIC OF SEONGNAM-SI GYEONGGIDO, 462-807. GE HEALTHCARE REPORTED A FIELD MODIFICATION FOR THIS IC9-RS DOUBLE IMAGE MALFUNCTION PER 21 CFR 806 ON (B)(6) 2023. THE FDA RECALL NUMBER IS 8020021-12/29/23-001-C. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND REQUESTING THE CUSTOMER TO PERFORM AN INSPECTION TEST TO DETERMINE IF THE PROBE IS MALFUNCTIONING. GE HEALTHCARE HAS DETERMINED THE CAUSE OF THE MALFUNCTIONING PROBE TO BE A PROBE COMPONENT. GE HEALTHCARE HAS REPLACED THIS MALFUNCTIONING PROBE. H3 OTHER TEXT : DEVICE PROBLEM ALREADY KNOWN, NO EVALUATION NECESSARY.

    Additional Manufacturer Narrative · 0

    THIS REPORT, 9710090-2024-00003, WAS FILED WITH THE INCORRECT LEGAL MANUFACTURER (HCS KOREA - 9, SUNHWAN-RO 214BEON-GIL JUNGWON-GU KOREA, REPUBLIC OF SEONGNAM-SI GYEONGGIDO, 462-807) AND THEREFORE HAS THE INCORRECT REPORT ID. THE REPORT WITH THE CORRECT LEGAL MANUFACTURER (HCS KRETZ - TIEFENBACH 15 AUSTRIA ZIPF OBEROSTERREICH, 4871) HAS BEEN FILED AND IS REPORT ID 8020021-2024-00118. THEREFORE, REPORT ID 8020021-2024-00118 REPLACES THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER PERFORMED AN INSPECTION TEST AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE ON (B)(6) 2023 (RECALL NO. 8020021-12/29/23-001-C), AND IT WAS CONCLUDED THE IC9-RS DIAGNOSTIC ULTRASOUND PROBE WAS IDENTIFIED AS HAVING A COMPONENT MALFUNCTION DESCRIBED IN RECALL NO. 8020021-12/29/23-001-C. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420680 IC9-RS DIAGNOSTIC ULTRASOUND TRANSDUCER ITX GE ULTRASOUND KOREA, LTD. H48691PJ 1194136WX6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown