MAUDE Adverse Event Report: KONICA MINOLTA, INC. KONICA; SYSTEM, X-RAY, STATIONARY

Device Problems Poor Quality Image (1408); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2019

Event Type  malfunction  

Event Description

I took the patient in the room.I laid one sheet on the table and grabbed another sheet to cover him.I held up the sheet and asked him to lower his shorts to about his knees.I then instructed him to lay down and i would cover him.He started to ask questions about how bad this was for his genitals.I do not remember his exact words.I do not remember my exact words.I said something like it isn't good for that area but i would shield him.I had been lining the machine up and looking for my landmarks on him while we were talking.After answering his question and finishing line up, i turned to get our shield.I placed the shield over the area of his gonads without touching him, but still keeping it out of the light field.I went behind the glass to take the exposure.The first time i tried to take the exposure, it beeped at me.No exposure was taken.I looked to see why it beeped.I took it off the anteroposterior (ap) sacroiliac (si) and put it on si oblique and switched it back again.I took the exposure.The image that came up was barely visible.I took it off of automatic exposure control (aec) on the panel and did a manual technique.That was too low.I did another manual technique and this image was good.The last 2 exposures were of the si obliques.My markers were cut off, so i left him lay on the table when i fixed my images that i was keeping and discarded the other two.I came and told him we were finished.I moved the tube, removed the shield, removed my marker, and lowered the table.I turned my back while he got up and pulled up his pants.I asked if he was finished getting dressed and then took him back to his room where i had found him.I then completed my study.

• Brand Name: KONICA
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): KONICA MINOLTA, INC.; 140 e 45th st fl 25; new york NY 10017
• MDR Report Key: 8586153
• MDR Text Key: 144284408
• Report Number: 8586153
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6205 DA