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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KONICA MINOLTA HEALTHCARE AMERICAS, INC. CS-7 SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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KONICA MINOLTA HEALTHCARE AMERICAS, INC. CS-7 SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Device Problems Image Reversal (1358); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2017
Event Type  malfunction  
Event Description
Chest x-ray was done with baby head down in a giraffe bed due to positioning for the endotracheal tube connected to oscillator at the foot of the bed and the baby could not be repositioned. Technologist rotated the image up/down on the machine for the doctor to be able to view the image in a head-up position on the portable screen. Tech verbalized that she was unsure but thought the laterality might be flipped due to the up/down flip. Because of a large tension pneumothorax, anatomic markers were not clear. Technologist left the nicu to return to imaging and annotate laterality with the assistance of her team lead. Meanwhile, the baby continues to decline and a code is initiated. The doctor determined a chest tube was needed emergently. Within a few minutes of the x-ray being taken, before the official radiology read, the nicu physician places a chest tube based on the image he viewed on the portable monitor. Routine confirmation x-ray of the chest tube shows it was placed on the opposite side than intended. A second chest tube is placed to address the original pneumothorax. Follow up simulation of the event determined a very complex software interface made it challenging for technologists to quickly select image adjustment options and clearly understand how the selection might impact the image in multiple directions. Human factors engineer completed usability study of the (b)(6) software involved in the event.
 
Event Description
Chest x-ray was done with baby head down in a giraffe bed due to positioning for the endotracheal tube connected to oscillator at the foot of the bed and the baby could not be repositioned. Technologist rotated the image up/down on the machine for the doctor to be able to view the image in a head-up position on the portable screen. Tech verbalized that she was unsure but thought the laterality might be flipped due to the up/down flip. Because of a large tension pneumothorax, anatomic markers were not clear. Technologist left the nicu to return to imaging and annotate laterality with the assistance of her team lead. Meanwhile, the baby continues to decline and a code is initiated. The doctor determined a chest tube was needed emergently. Within a few minutes of the x-ray being taken, before the official radiology read, the nicu physician places a chest tube based on the image he viewed on the portable monitor. Routine confirmation x-ray of the chest tube shows it was placed on the opposite side than intended. A second chest tube is placed to address the original pneumothorax. Follow up simulation of the event determined a very complex software interface made it challenging for technologists to quickly select image adjustment options and clearly understand how the selection might impact the image in multiple directions.
 
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Brand NameCS-7
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
2217 us highway 70 e
garner NC 27529
MDR Report Key7479460
MDR Text Key107120635
Report Number7479460
Device Sequence Number0
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/04/2018
Event Location Hospital
Date Report to Manufacturer04/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/02/2018 Patient Sequence Number: 1
Treatment
NO
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