MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD

Model Number 414007

Device Problems Poor Quality Image (1408); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  malfunction  

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2021.The reporter states that images are white-washed, and a message had come up regarding calibration, and is not letting them take any exposures.The reporter states that the event happened during a procedure and the procedure was not completed, with no injury to patient or staff.

Manufacturer Narrative

Overall investigation summary: a complaint was received from a customer on a urology system serial number (b)(4) alleging images were washed out and the system was showing a message regarding calibration and not letting user takes any exposures.The operator rescheduled the case.There was no patient injury reported.Fse arrived on site to investigate but was unable to duplicate the reported issue of the images being washed out.Fse spoke to the imaging engineer and was told the user had received a message of images being disabled due to the detector performing calibration.Fse explained that this is a standard message and that the user must wait for this application to complete calibration before proceeding with an exposure.As noted in the nexus computer operator's manual: "x-ray detector calibration takes place automatically in the background in i5 nexus's idle mode and at the beginning of acquire mode.During this calibration, the detector status indicates that it is busy.X-ray radiation is prohibited during the calibration." there were no problems found with the system.Fse verified operation according to service checklist (b)(4) and returned the system to customer use.A review of cts shows a similar issue reported from this customer in 2018 on same system where operator completed that case with no further issue.Reference complaint (b)(4) for further details.Impact assessment summary.No injuries reported.Personnel - training - inadequate.Root / probable cause summary: refer to investigation summary.No further investigation needed at this time.Qa will continue to monitor and trend for similar issues.No capa at this time, these trends and issues are reported on during quality metrics review and during the management review meetings to consider input for corrective action.Disposition summary: unit remained in service.

• Brand Name: HUT EXT DR FINAL ASSY,RE,FPD
• Type of Device: HUT EXT DR FINAL ASSY,RE,FPD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 12861056
• MDR Text Key: 282344141
• Report Number: 1518293-2021-00038
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414007
• Device Lot Number: CI0317H680
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female