BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN GAMMA CAMERA SYSTEM

    MDR report key: 3397498 · Received October 2, 2013

    Report

    Report Number
    9616576-2013-00001
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 21, 2013
    Manufacturer
    DDD-DIAGNOSTIC A/S
    Product Code
    KPS
    PMA / PMN Number
    K001888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTIONS: NO FIELD CORRECTIVE ACTIONS TO INSTALLED DEVICES ARE NECESSARY. THE INCIDENT IS CONSIDERED TO BE A SINGLE INCIDENT NOT RELEVANT FOR THE REMAINING INSTALLED BASE. ALL FAILING PARTS HAS BEEN REMOVED FROM THE INCIDENT SITE. CONCLUSION: BLOCKING OF LOCK # 1 HAS CAUSED THE LOCK NOT BEING ABLE TO "FLOAT" WITHIN THE COLLIMATOR BUSHING RESULTING IN UNRELIABLE LOCKING - LOCK#1 BEING PARTLY BLOCKED WILL CAUSE UNRELIABLE LOCKING OF LOCK # 2. IN THE SITUATION HAVING THE COLLIMATOR PARTLY LOCKED TO THE DETECTOR, AND NOT BEING SUPPORTED BY THE EXCHANGER, THE USER HAS MANUALLY ROTATED THE LOCKING DEVICES WHICH EVENTUALLY HAS CAUSED THE COLLIMATOR TO FALL. CORRECT FUNCTION COULD HAVE BEEN MAINTAINED IF THE ITEM HAD BEEN IDENTIFIED AND REMOVED DURING ROUTINE INSPECTIONS OF THE COLLIMATOR LOCKS. NOT PERFORMING THE ROUTINE INSPECTIONS OF THE COLLIMATOR AS INDICATED IN THE USER MANUAL HAS IN THIS CASE RESULTED IN COMPROMISING THE SYSTEM SAFETY. A RISK PRODUCT OF 10 WILL, ACCORDING TO DDD'S RISK MGMT PROCEDURE, NOT CALL FOR ACTIONS FOR FURTHER MITIGATION TO REDUCE RISK. THIS WILL CLOSE THE HANDLING OF THIS INCIDENT.

    Description of Event or Problem · 1

    TRIP REPORT RECEIVED (B)(6) 2013 (FROM PHILIPS). THE CUSTOMER WANTED TO REMOVE THE COLLIMATOR WITHOUT SUCCESS AND DID PLAY WITH THE LATCHES MANUALLY. DURING THE REMOVAL OF THE COLLIMATOR LEHR FOR AN INTRINSIC QC, THE CUSTOMER FOLLOWED THE PROCEDURE AND WAS NOT ABLE TO REMOVE THE COLLIMATOR. THE CUSTOMER DID ROTATE THE DETECTOR TO 90 DEGREES AND SAW ONE OF THE FOUR LATCHES NOT IN THE SAME ORIENTATION. THE CUSTOMER DID USE A TOOL TO PLACE THE LATCHES IN THE SAME ORIENTATION. THEN, THE CUSTOMER ASKED FOR A PRE-PROGRAM MOTION. THE SYSTEM DID START TO ROTATE AND THE COLLIMATOR FELL ON THE FLOOR. NOBODY WAS HURT, ONLY THE COLLIMATOR WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498349 MERIDIAN GAMMA CAMERA SYSTEM NUCLEAR MEDICINE EQUIPMENT KPS DDD-DIAGNOSTIC A/S NA

    Patients

    Seq Age Sex Outcome Treatment
    1