BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHA GAMMA CAMERA

    MDR report key: 382 · Received March 18, 1992

    Report

    Report Number
    382
    Event Type
    Malfunction
    Date Received
    March 18, 1992
    Date of Event
    February 19, 1992
    Report Date
    March 5, 1992
    Manufacturer
    SOPHA MEDICAL SYSTEMS, INC.
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THREE REPORTS OF "UNINTENDED RADIAL MOTION OF THE CAMERA HEAD" SOPHA HAS SENT OUT A SAFETY ALERT BECAUSE THEY HAD RECEIVED SEVERAL REPORTS OF THIS TYPE OF MALFUNCTION WITH THEIR PRODUCTINVALID 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR, DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHA GAMMA CAMERA GAMMA CAMERA IYX SOPHA MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other