BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IC9-RS

    MDR report key: 20052102 · Received August 23, 2024

    Report

    Report Number
    8020021-2024-00475
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 23, 2024
    Manufacturer
    GE HEALTHCARE AUSTRIA GMBH & CO OG
    Product Code
    ITX
    PMA / PMN Number
    K213689
    Removal / Correction Number
    Z-0865-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS KRETZ - TIEFENBACH 15 AUSTRIA ZIPF OBEROSTERREICH, 4871. GE HEALTHCARE REPORTED A FIELD MODIFICATION FOR THIS IC9-RS DOUBLE IMAGE MALFUNCTION PER 21 CFR 806 ON 29-DEC-2023. THE FDA RECALL NUMBER IS Z-0865-2024. 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 WILL REPLACE THE PROBE UPON COMPLETION OF THE FIELD ACTION AT THIS SITE. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY SPECIFIC PRIVACY LAWS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DOUBLE IMAGE WHEN USING THE PROBE DURING A PATIENT EXAM. IT WAS CONCLUDED THIS IC9-RS DIAGNOSTIC ULTRASOUND PROBE WAS IDENTIFIED AS HAVING A COMPONENT MALFUNCTION DESCRIBED IN RECALL NO. 8020022-12/29/23-001-C. THE PROBE WAS IN USE AT THE TIME OF THE MALFUNCTION BUT THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582190 IC9-RS DIAGNOSTIC ULTRASOUND TRANSDUCER ITX GE HEALTHCARE AUSTRIA GMBH & CO OG H48691PJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female