BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE X-RAY MACHINE AMX-110

    MDR report key: 4327 · Received February 9, 1993

    Report

    Report Number
    4327
    Event Type
    Malfunction
    Date Received
    February 9, 1993
    Date of Event
    December 11, 1992
    Report Date
    February 9, 1993
    Manufacturer
    G.E. MEDICAL SYSTEMS
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SPARKS ARKED FROM PLUG WHEN INSERTED INTO WALL PLUG. NO HARM TO PATIENT OR OPERATOR. FRAYED CORD REPLACED AND SAFETY INSPECTED BY MAINTENANCEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE X-RAY MACHINE AMX-110 IZL G.E. MEDICAL SYSTEMS 46-165600G7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other