BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICORN MODEL SYS0630 MERIDIAN I

    MDR report key: 2180561 · Received July 25, 2011

    Report

    Report Number
    9616576-2011-00003
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 20, 2011
    Manufacturer
    DDD-DIAGNOSTIC
    Product Code
    KPS
    PMA / PMN Number
    K001888
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY, ARM INJURY, MERIDIAN 1. THIS WILL CLOSE THE HANDING OF THIS INCIDENT. INVESTIGATION SUMMARY: INCIDENT DESCRIPTION: THE PATIENT HAD AN ACTIVE INJECTION SITE, THAT MEANS SHE WAS PARA INJECTED. SO THE ACTIVITY OF THE REST OF HER BODY WAS TOO WEAK. THEREFORE THEY REPEAT THE SCAN WITH A NORMAL PROTOCOL FOR WHOLE BODY FROM ABOVE AND BELOW. TO SEE MORE ACTIVITY THEY PUT THE ARM FROM THE PATIENT ON A TROLLEY. THEN THE GANTRY DROVE TO THE BELOW POSITION (THIS POSITION WAS NOT NEEDED) AND THE DETECTOR EDGE PINCHED PATIENT'S ARM. INCIDENT REPORTED TO DDD (B)(6) 2011. CONCLUSION: A RISK PRODUCT OF 8 WILL, ACCORDING TO DDD'S RISK MANAGEMENT PROCEDURE, NOT CALL FOR ACTIONS FOR FURTHER MITIGATION TO REDUCE RISK. BASED ON THE INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE HAS BEEN WORKING ACCORDING TO ITS SPECIFICATIONS AND THAT THE CAUSE OF THE INCIDENT WAS INCORRECT SETUP AND USE OF THE DEVICE. FURTHER IT HAS BEEN CONDUCTED THAT THE INCIDENT ARE TO BE CONSIDERED TO BE ISOLATED CASE CAUSED BY A HUMAN ERROR. THIS WILL CLOSE THE HANDLING OF THIS INCIDENT.

    Description of Event or Problem · 1

    THE OPERATOR SET UP A SPECT PROTOCOL FOR VENTRAL AND DORSAL IMAGING. AFTER THE VENTRAL IMAGE WAS PERFORMED, THE PATIENT MOVED AND SPREAD/BRACED HER ARM. ACCORDING TO THE PROTOCOL SETUP, THE GANTRY MOVED AUTOMATICALLY FROM THE BOTTOM TO THE TOP TOWARDS DORSAL AND SQUASHED THE PATIENT'S ARM. THE X-RAY ASSISTANT WANTED TO STOP THE GANTRY AND SELECTED STOP ON THE IMAGE PROTOCOL OF THE ACQUISITION COMPUTER, BUT THE GANTRY DID NOT STOP THE ROTARY MOVEMENT. THEREON THE X-RAY ASSISTANT PUSHED THE E-STOP BUTTON AND THE GANTRY STOPPED. THE OPERATOR REMOVED THE PATIENT FROM THE GANTRY AND THE PATIENT WAS SENT TO THE HOSPITAL FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICORN MODEL SYS0630 MERIDIAN I NUCLEAR MEDICINE EQUIPMENT KPS DDD-DIAGNOSTIC 9SYS0630-A02

    Patients

    Seq Age Sex Outcome Treatment
    1