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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 Self-Activation or Keying (1557); Failure to Read Input Signal (1581)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary: a customer notified guerbet service that the hut system kept fluoroing approximately 20 seconds after releasing the footswitch. Guerbet sent their field service engineer (fse) on-site to check the system. During his visit, the fse reported that the system was operating as designed and could not duplicate the complaint issue, as the system was fully functional. After verifying the system was fully operational using service checklist qssrew4. 3, the fse returned the system to full service. During his visit, the fse retrieved the system event logs and forwarded these to varex, the manufacturer of the imaging system, for analysis. Although varex examined the event logs they were not able to determine the cause as the data by that time had been overwritten. A review of guerbet's compliant tracking system revealed that the last issue involving fluoro was reported (b)(6) 2017. Although the issue was related to the footswitch, the fse went on site but could not duplicate the issue. Root / probable cause code: unknown. 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 returned to service.
 
Event Description
This incident was reported on (b)(6) 2019, as customer reported that during an xray, the doctor tried to spot film and took but not a diagnostic image. Further clarification was found in the tech support notes, where the reporter stated that the doctor was in mag 3 when the incident occurred. He stated that the when doing a digital spot, the image was grainy. The doctor then tried a fluoro and when letting off foot switch, the system kept fluoroing for about 20 seconds (system dose and time kept counting). The reporter stats that the they shut the system down and turned it back on. The system functioned normally, and the reporter wrote down the time and date when the incident occurred. The reporter states that this incident happened during a procedure and the procedure was completed, and that there was no injuries to patient or staff.
 
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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 road
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, OH 45237
MDR Report Key8883348
MDR Text Key203647520
Report Number1518293-2019-00016
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 faci
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 06/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number414007
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 Received06/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2016
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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