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Model Number 404008
Device Problems Corroded (1131); Mechanical Problem (1384); Moisture Damage (1405); Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2018
Event Type  malfunction  
Manufacturer Narrative
Biomed called service reporting that with a patient on the table, they had a system message saying `align system chain needed'. The biomed had tried pressing the `imaging chain' key, but system would not automatically re-align. The hut system safety interlock will not allow fluoro if the proper alignment isn't achieved. Tech support helped biomed troubleshoot and also found that normal table movement was lost because the users had moved table splash/crash cover into an object. Biomed physically moved the cover to release the limit switches and all table movements were restored except for the image chain alignment. Patient was then moved to complete the procedure. When biomed called back to service, he reported that he had troubleshot the alignment issue to a corroded transducer. Amplifier board under the table. The biomed had replaced the transducer amplifier board and the system was fully functional. Tech support asked biomed where he got the replacement board, and he indicated he got it through his central ordering service. Tech support checked and was not able to find that it was purchased through guerbet service. A review of cts shows a similar table misalignment issue reported on this unit in 2013. This is a known issue, reference ci-capa-(b)(4), in which `no fluoro 'tube carriage and no table movement issues were identified as complaint trends where the most common part identified with the issue was pn 400813 pcba. No further investigation needed at this time. Qa will continue to monitor and trend for similar issues. These trends and issues are reported on during quality metrics reviews and during the management review meetings.
Event Description
Initial complaint received on (b)(6) 2018. Reporter notified guerbet of mechanical failure - alignment. Reporter states that the align image chain needed to be performed, and that the patient is on the table. Reporter attempted to realign the image chain but it would not automatically align when pressing the imaging chain key. Reporter indicated the users have crashed the splash/crash guard into an object. This is known because he had to move the guard to release the limit switches. All the table movements were then restored except for the image chain alignment. The patient had to then be moved because the image chain would not realign due to this operator error. Report receiver received an update on 27 august 2018 in which a transducer amplifier was found to be corroded for the image intensifier. The customer ordered and replace the transducer amplifier, p/n 400813. The system is now fully functional. This would be a sign that a leak occurred in the table which affected the board causing malfunction.
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Manufacturer (Section D)
2111 e galbraith road
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, OH 45237
MDR Report Key7894097
MDR Text Key121567969
Report Number1518293-2018-00034
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number404008
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage