BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NM/CT 860

    MDR report key: 16186348 · Received January 17, 2023

    Report

    Report Number
    9613299-2023-00005
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    December 21, 2022
    Report Date
    July 25, 2023
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL
    Product Code
    KPS
    PMA / PMN Number
    K173816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXECUTION OF FMI 40901 BY A GEHC FIELD ENGINEER REVEALED A SAFETY KEY WAS MISSING. THE FE REPAIRED THE SYSTEM AND RETURNED IT TO CUSTOMER USE. INVESTIGATION AND RISK ASSESSMENT HAVE CONCLUDED THAT THE SYSTEM WAS MISSING A KEY PRIOR TO SHIPMENT. THE KEYHOLE HAD LOCTITE RESIDUE, INDICATING THE KEY WAS DISLODGED DURING THE MANUFACTURING PROCESS. GEHC HAS IMPLEMENTED CORRECTIVE ACTIONS (INCLUDING UPDATES TO THE MANUFACTURING PROCESS, GEAR REPLACEMENT PROCESS) TO ADDRESS ROOT CAUSES AND PREVENT RECURRENCE.

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). LEGAL MANUFACTURER: (B)(4). GE HEALTHCARE (GEHC) REPORTED RECALL C/R#: 9613299-01/03/23-001-C. PER 21 CFR 806 ON 3-JAN-2023 DUE TO AN INTERNAL FINDING INDICATING THAT THE SAFETY KEY FOR CERTAIN NM DEVICES MAY NOT HAVE BEEN CORRECTLY IMPLEMENTED. AS PART OF THIS RECALL, THIS SYSTEM WAS INSPECTED, CORRECTED, AND RETURNED BACK TO CLINICAL USE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 0

    AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) (RECALL FMI 40901), THIS UNIT WAS IDENTIFIED AS MISSING THE SAFETY KEY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172101 NM/CT 860 SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION KPS GE MEDICAL SYSTEMS ISRAEL NMHS86

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown