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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD
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LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD Back to Search Results
Model Number 414007
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/22/2019
Event Type  malfunction  
Event Description
This incident was reported on (b)(6) 2019, as the system is unable to acquire images when fluoro.This incident occurred during a procedure where the patient was connected.The procedure was not completed, and there was no injury to the patient or staff.The reporter states that the system is unable to acquire images when fluoroing, and reported it as an intermittent issue.
 
Event Description
This incident was reported on (b)(6) 2019, as the system is unable to acquire images when fluoro.This incident occurred during a procedure where the patient was connected.The procedure was not completed, and there was no injury to the patient or staff.The reporter states that the system is unable to acquire images when fluoroing, and reported it as an intermittent issue.This supplemental report is created to document the overall investigation summary, as well as the root probable cause code and summary, and disposition summary, which was made available june 10th, 2019.
 
Manufacturer Narrative
Overall investigation summary: a hospital contacted guerbet technical services stating that intermittently, their ddis urology system is unable to produce fluoro images.A guerbet field service engineer (fse) went on site to check system.The fse reported that he could not duplicate the complaint or produce any errors.The fse verified proper operation by completing the service checklist qssrwi4.3.After verifying that the system was functioning according to specifications, it was returned to service.Prior to leaving the account, the fse retrieved the event logs from the system and forwarded these to the varex, the supplier of the imaging system.Varex's technical support reviewed the event logs for the 3-day period identified by the customer as having intermittent no-fluoro issues.Varex's technical support found that the `no fluoro' issue reported on (b)(6) 2019, was due to a series of events that were user error related.The customer then returned next day (b)(6) 2019, and operated the system with no issues.The next use of system was on (b)(6) 2019, the user opened a case file, completed a flouro image, and then after a 45 min.Delay, attempted another fluoro that did not occur.Varex found that the root cause of this failure was the long delay time between fluoro requests.This inactivity allowed the unitrans board inside the nexus computer to go into sleep mode, loosing communication with the image detector.A reboot of the nexus imaging computer reestablished the communication, and allow the system to function properly to complete the procedure.A 3 year review of guerbet's complaint tracking system indicated no similar user issues reported on this unit.Root/probable cause code: process/methods - inadequate/incorrect procedure.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 full service.
 
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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
MDR Report Key8627806
MDR Text Key146664450
Report Number1518293-2019-00008
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
PMA/PMN Number
K121838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number414007
Date Manufacturer Received04/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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