MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HVDIS TABLE, REVERSE WITH FPD

Model Number 424007

Device Problem Failure to Align (2522)

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

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: guerbet technical support received a call from a hospital biomed stating that while a patient was on the table, their hvdis urology system, stopped producing x-rays.Although the biomed rebooted the imagining computer, they were unable to regain x-ray imaging.There was no harm to the patient, which was moved to another system to complete the procedure.Guerbet's technical support advised the biomed that the system may need to be reset by rebooting both the imaging computer as well as the generator.After performing the reset, xray ability was regained, and the system functioned normally.The event logs from both the imaging computer and the generator were downloaded for review by the manufacturers.Based on this review varex, the imaging system manufacturer, concluded that the operator removed his foot from the exposure foot pedal before the acquisition sequence was finished.This condition caused the generator to be out of synchronization with the imaging computer.When this occurred, the generator stopped producing pulses and sent an error code 57 to the imaging computer.Although it rarely occurs, this situation, in which the generator and computer loose communication when the user releases the `expose' pedal too soon is a software anomaly known by varex who issued technical advisory #227, which was explained to users.Varex will resolve this issue in an upcoming varex software enhancement version (b)(4), per the advisory notice.Root / probable cause code: equipment/instrument - software.Root / probable cause summary: refer to investigation summary : this is a known issue; the operator letting his/her foot off the pedal too soon, while being an operator error, can cause a situation where the system gets locked.That this happens is a software anomaly known by varex who issued a technical advisory #227 which was sent to service and applications personnel and explained to users.The ultimate fix will be in the next varex software enhancement, version (b)(4) 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.

Event Description

Initial information was received on (b)(6) 2020, as reporter states that there was no patient on the table at the time of the first message on the system, which displayed that the x-ray tube is misalligned, but moved the imaging chain to rectify the interlock.They then perfomed a cas without issue.Reporter states that on the 2nd case, the system stopped makign x-ray.They cycled the nexus only, but did not get x-ray back.At this point, they moved the patient to another room.Reporter states that there are no messages on the table or the generator menu bar.The detector status is green.Reporter was told to cycle power on the spellman, but this did not help.The reporter then cycled power on the nexus and spellman, and this action rectified the issue.

• Brand Name: HVDIS TABLE, REVERSE WITH FPD
• Type of Device: HVDIS TABLE, REVERSE WITH FPD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati, oh
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, oh
• MDR Report Key: 9961992
• MDR Text Key: 196134118
• Report Number: 1518293-2020-00007
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 424007
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1