MAUDE Adverse Event Report: LIEBEL-FLARSHEIM LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM; Solid State X-ray Imager

Model Number 404008

Device Problem Output Problem (3005)

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: a hospital's imaging specialist contacted guerbet's technical support department, stating that although their hydravision urology system would take "table top" x-ray shots, it was not producing fluoroscopic images.When trying to take fluoroscopic images, the x-ray tube would warm-up and the system would display the "preparing to expose" message, but when the foot pedal was released, the system would display an "exposure cancelled" message.After rebooting the system and experiencing the same results, the customer requested support from crothall, their 3rd party service provider.Crothall's biomed attempted to diagnose and repair the system, but in the process damaged the cable between the console cpu, and the generator's interface atp board, which controls the generator's fluoro production.As a result, crothall advised their customer to have guerbet service the system.On (b)(6) 2020, guerbet's field service engineer (fse) was called to the facility to perform the repair.Although the fse could not determine the cause of the initial no-fluoro issue, he did confirmed the damage to the cable.After replacing the cable the fse discovered a failed atp interface board.After replacing the failed circuit board, the fse verified proper operation of the system using hut service checklist qssrwi.4.1 and returned the unit to full service.A review of guerbet complaint tracking system (cts) showed no related complaint activity for this device.Root / probable cause code.Equipment/instrument - failure.Root / probable cause summary.What caused the atp board to become defective is unknown and appears to be an isolate occurrence.Therefore, no further investigation needed at this time.Guerbet's quality organization will continue to monitor and trend any similar issues.No capa required at this time, such items are trended during quality metrics review and management review meetings for additional corrective action consideration.Disposition summary unit returned to full service.

Event Description

These incidents were reported by a facility in (b)(6) on (b)(6) 2020.Reporter states that system will not fluoro, stating that the system will make table top shot and will take tube warm up.When attempting to fluror the system will state preparing to expose, and when foot pedal is released, the system will state exposure cancelled.Reporter states that they shut down all systems, table and generator, gim box, and imaging tower.Next, they booted systems back up and opened an emergency patient, attempted fluoro and received same symptoms.The reporter states that the events happened during a procedure, but that the patients were not connected and there was no injury to patient or staff.

• Brand Name: LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
• Type of Device: Solid State X-ray Imager
• 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: 11132271
• MDR Text Key: 245338838
• Report Number: 1518293-2020-00045
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/11/2020

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: 404008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1