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

Model Number 414007

Device Problems Self-Activation or Keying (1557); Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: a customer notified guerbet service that the hut system kept fluoroing approximately 20 seconds after releasing the footswitch.Guerbet sent their field service engineer (fse) on-site to check the system.During his visit, the fse reported that the system was operating as designed and could not duplicate the complaint issue, as the system was fully functional.After verifying the system was fully operational using service checklist qssrew4.3, the fse returned the system to full service.During his visit, the fse retrieved the system event logs and forwarded these to varex, the manufacturer of the imaging system, for analysis.Although varex examined the event logs they were not able to determine the cause as the data by that time had been overwritten.A review of guerbet's compliant tracking system revealed that the last issue involving fluoro was reported (b)(6) 2017.Although the issue was related to the footswitch, the fse went on site but could not duplicate the issue.Root / probable cause code: unknown.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 returned to service.

Event Description

This incident was reported on (b)(6) 2019, as customer reported that during an xray, the doctor tried to spot film and took but not a diagnostic image.Further clarification was found in the tech support notes, where the reporter stated that the doctor was in mag 3 when the incident occurred.He stated that the when doing a digital spot, the image was grainy.The doctor then tried a fluoro and when letting off foot switch, the system kept fluoroing for about 20 seconds (system dose and time kept counting).The reporter stats that the they shut the system down and turned it back on.The system functioned normally, and the reporter wrote down the time and date when the incident occurred.The reporter states that this incident happened during a procedure and the procedure was completed, and that there was no injuries to patient or staff.

• 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 road; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, OH 45237
• MDR Report Key: 8883348
• MDR Text Key: 203647520
• Report Number: 1518293-2019-00016
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414007
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1