MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD

Model Number 404008

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

Field service engineer (fse) went on site to investigate customer's report that during a case the system would not allow fluoro.When the fse arrived, he found the system was fully functional.The fse could not duplicate the no fluoro issue as he was able to fluoro and perform digital spot without any problem.Varex review of the logs pulled from the imaging computer found no issue recorded.Fse spoke to the x-ray tech who experienced the issue who said that a "fault alarm reset" message was seen flashing on the generator console during the time that the fluoro had stopped, and that she had shutoff generator console and issue was resolved.When a generator fault alarm occurs on this system, the generator will not allow further exposures until the fault alarm is acknowledged by the operator, either by touching the flashing button that says "fault alarm reset", or as in this case, by the operator who power cycled the generator.Both result in resetting the fault alarm and resetting the generator.After the fault alarm reset, the generator will again allow fluoro / exposures.The operator did not note that alarm was in the `error center' of the generator console when the fault alarm reset button was flashing.It is not known what caused this fault alarm, as it may have been due to an operator error with the foot pedal as surmised by the fse or could have been due to an issue in the generator.System remained in full service.After investigating the system, the fse verified operation according to hut dr service checklist qssrwi4.1 and returned the unit to full service.

Event Description

Incident: lft htdr x-ray/fluoro issues - stopped flouring.During a case the system would not allow fluoro.The x-ray tech who experienced the issue who said that a "fault alarm reset" message was seen flashing on the generator console during the time that the fluoro had stopped, and that she had shutoff generator console and issue was resolved.The operator did not note what alarm was in the `error center' of the generator console when the fault alarm reset button was flashing.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• 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: 7836761
• MDR Text Key: 119661507
• Report Number: 1518293-2018-00029
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2018

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: 07/24/2018
• Initial Date FDA Received: 08/31/2018
• Date Device Manufactured: 04/30/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1