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U.S. Department of Health and Human Services

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

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LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD Back to Search Results
Model Number 404008
Device Problems Leak/Splash (1354); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2019
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary on (b)(6) 2019, a customer called guerbet service to report that a "strange noise" was coming from their hut urology system, but could not identify which part of the system the noise was coming from. During the call, the customer stated that the system is still fully operational and that no alarms or error codes have been displayed. Several mins later the customer reported that although there was no injury to the patient, a small spot of oil had dripped from the x-ray tube onto a patient during a procedure. On july 25, 2019 guerbet service sent their field service engineer (fse) on-site to examine the system. During the visit, the fse replaced the reported leaking x-ray tube. However, since the replacement tube, serial number (b)(4), could not be calibrated, the fse ordered a replacement x-ray tube, serial number (b)(4), and returned on july 29th to install and calibrate it. After verifying proper operation per service checklist (b)(4), the system was returned to full customer use. Then on (b)(6) 2019, the customer called guerbet service, again reporting that although there was no patient harm, the new x-ray tube had over-heated and leaked small spot of oil onto the patient's blanket during a procedure. Guerbet service issued service ticket (b)(4), complaint (b)(4) to have the system examined. Guerbet's fse revisited the account on august 8, 2019, to investigate the alleged leaking x-ray tube. During this visit the fse confirmed that oil had leaked form the x-ray tube's pressure relief port. Believing the x-ray tube was defective, the fse replaced it with another new tube serial (b)(4). While testing the new tube, the fse noticed a strange noise coming from the x-ray generator, and replaced the generator's digital rotational anode controller (drac) assembly (pn a6378-27). After replacement, the noise remained. With the assistance of l-f and sedecal, the x-ray generator manufacture's technical service support, the problem was isolated to the u17 chip on the drac printed circuit board. The u17 chip was replaced on the original drac board and placed back into the generator. After the system was verified to meet specifications by the completion of the hydravision dr system service checklist (b)(4), the system was returned to full service. Root/probable cause code: equipment/instrument - failure. Root / probable cause summary: equipment/instrument - failure the u17 eprom on the generator's drac board, calculates and monitors the heat units of the x-ray tube based on number of xrays and fluoros executed within a given time period. Additionally, this chip received signals from the tube of its temperature conditions. The malfunction of this component allowed the x-ray tube to slightly over-heat, causing a small amount of cooling fluid (oil) to exit the tubes pressure relief port. Disposition summary: unit returned to service.
 
Event Description
This incident was reported on (b)(6) 2019, as customer called to report that a "strange noise" was coming from their hut urology system, but could not identify which part of the system the noise was coming from. During the call, the customer stated that the system is still fully operational and that no alarms or error codes have been displayed. Several mins later the customer reported that although there was no injury to the patient, a small spot of oil had dripped from the x-ray tube onto a patient during a procedure.
 
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Brand NameHUT EXT DR FINAL ASSY-STANDARD
Type of DeviceHUT 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 Key9117893
MDR Text Key220190958
Report Number1518293-2019-00021
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2011
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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