BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOGRAPHY

    MDR report key: 431 · Received March 30, 1992

    Report

    Report Number
    431
    Event Type
    Malfunction
    Date Received
    March 30, 1992
    Date of Event
    February 26, 1992
    Manufacturer
    SIEMENS
    Product Code
    IYQ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT HAVING A MAMOGRAM (LEFT AXILLARY VIEW) - MACHINE SHUT DOWN DURING EXPOSURE BEFORE FILM WAS EXPOSED. PT WAS IN FULL COMPRESSION FOR ABOUT 2 MINUTES BEFORE MACHINE WOULD COME BACK UPDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: .DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED, OTHER, OTHER. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA, INVALID DATA. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, DEVICE FAILED DURING ASSEMBLY, DEVICE FAILED JUST PRIOR TO USE, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, INVALID DATA, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOGRAPHY IYQ SIEMENS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other