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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,ST,FPD

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LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,ST,FPD Back to Search Results
Model Number 414008
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary impact assessment summary a hospital biomed contact guerbet service to report that with a (b)(6) lbs. Patient on the table, their hut dr urology system's table started to move in a trendelenburg position without being commanded by the user. There was no harm to the patient as the patient was removed from the table by the hospital staff. Guerbet technical services followed-up with a phone call to the biomed, then sent their field service engineer (fse) on-site to investigate this complaint. The fse reported that upon arrival, the table was in the horizonal position. The fse tested the table, but could not duplicate the issue. During the investigation, the fse did noticed that when traversing the table from the trendelenburg position, a directional error occurred. The system identified that the table was in the horizonal position, when in fact it was not. The fse then reseated the longitudinal transducer amp pc board and retested the system. No further errors occurred. Therefore, the fse verified proper system operation according the lfddis system service checklist qssrwi4. 3. As the system proved fully functional, it was returned to full service. A review of cts shows no similar issue previously reported on this unit. Root / probable cause code: unknown. Root / probable cause summary: unknown. 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
Initial information was received on 18 february 2020, as reporter states that a (b)(6)-lb. Patient was on the table, and the table started moving trendelenburg without a command from th user. The reporter states that the patient did not fall off the table. The reporter believes that they or staff took the patient off the table at this point. This event was reported to occur during a procedure and reporter states that the procedure was completed without any injury to patient or staff.
 
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Brand NameHUT EXT DR FINAL ASSY,ST,FPD
Type of DeviceHUT EXT DR FINAL ASSY,ST,FPD
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e galbraith road
cincinnati, oh
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, oh 
MDR Report Key9848956
MDR Text Key207756772
Report Number1518293-2020-00005
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 user facility
Reporter Occupation Biomedical Engineer
Remedial Action Repair
Type of Report Initial
Report Date 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number414008
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 Received02/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2015
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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