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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 Problems Poor Quality Image (1408); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Event Description
This incident was reported by a facility in (b)(6) on (b)(6) 2021. The reporter states that images are white-washed, and a message had come up regarding calibration, and is not letting them take any exposures. The reporter states that the event happened during a procedure and the procedure was not completed, with no injury to patient or staff.
 
Manufacturer Narrative
Overall investigation summary: a complaint was received from a customer on a urology system serial number (b)(4) alleging images were washed out and the system was showing a message regarding calibration and not letting user takes any exposures. The operator rescheduled the case. There was no patient injury reported. Fse arrived on site to investigate but was unable to duplicate the reported issue of the images being washed out. Fse spoke to the imaging engineer and was told the user had received a message of images being disabled due to the detector performing calibration. Fse explained that this is a standard message and that the user must wait for this application to complete calibration before proceeding with an exposure. As noted in the nexus computer operator's manual: "x-ray detector calibration takes place automatically in the background in i5 nexus's idle mode and at the beginning of acquire mode. During this calibration, the detector status indicates that it is busy. X-ray radiation is prohibited during the calibration. " there were no problems found with the system. Fse verified operation according to service checklist (b)(4) and returned the system to customer use. A review of cts shows a similar issue reported from this customer in 2018 on same system where operator completed that case with no further issue. Reference complaint (b)(4) for further details. Impact assessment summary. No injuries reported. Personnel - training - inadequate. 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 service.
 
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Brand NameHUT EXT DR FINAL ASSY,RE,FPD
Type of DeviceHUT EXT DR FINAL ASSY,RE,FPD
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e. galbraith rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
cincinnati, OH 45237
MDR Report Key12861056
MDR Text Key282344141
Report Number1518293-2021-00038
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number414007
Device Lot NumberCI0317H680
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2017
Is This a Reprocessed and Reused Single-Use Device? No

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