BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THYROID UPTAKE SYSTEM

    MDR report key: 1649 · Received November 2, 1992

    Report

    Report Number
    1649
    Event Type
    Malfunction
    Date Received
    November 2, 1992
    Date of Event
    October 20, 1992
    Report Date
    October 20, 1992
    Manufacturer
    CAPINTEC, INC.
    Product Code
    JZO
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THYROID SCANNER TUBE SYSTEM FELL. SCANNER WAS NOT IN USE AT THE TIME. THE TUBE SYSTEM IS ONE WHICH WEIGHS APPROXIMATELY 50LBS AND MAY BE PLACED DIRECTLY OVER THE THYROID (NECK) DURING USE. INTERNAL INVESTIGATION DETERMINED THAT THE PHOTOMULTIPLIER TUBE ASSEMBLY WAS INCORRECTLY INSTALLED, CAUSING THE TUBE TO FALL. THE PIVOT SHAFT WAS NEVER INSERTED PAST THE LOCKING SCREW POINT INTENDED TO PREVENT FALLING. THE REASON FOR THE REPORT IS THE POTENTIAL SERIOUSNESS OF THIS SITUATIONINVALID 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THYROID UPTAKE SYSTEM UNKNOWN JZO CAPINTEC, INC. TUS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other