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

Model Number 414008

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary is as follows: tech support spoke with biomed who reported an un-commanded table movement during a late night case.The endo group doing the procedure said the table moved up elevation to max height with a patient on the table.The patient was not injured, and case was completed.When the regular operating room group came in next morning, they were able to lower the table and could not repeat or find anything wrong with table.The biomed then was called in, and he too was able to operate table with no problems.Biomed said that even though he found no issue with table system, he decided to replaced the footswitch as a precaution.Tech support provided the replacement pn for biomed.On follow up call, biomed told tech support that he had ordered a replacement footswitch from a 3rd party supply.He also re-stated that he was not able to duplicate issue, and suspects this may have happened because the endo group was not as familiar with this room as are the cysto team.Biomed also declined a guerbet service visit to check the system.Root/probable cause code is as follows: 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 is as follows: unit remained in service.

Event Description

This incident was reported by a biomedical engineer from the user facility.The reporter states that there was a left ddis uncommanded movement, in which the table raised to maximum height with patient on the table.Reporter states that no harm to the patient was reported.This event took place on (b)(6) 2018.On 11 september 2018, report receiver spoke with biomedical engineer at user facility regarding this incident.Reporter said that late last night, the endo group, not the operating room group, was using the table and the table moved up elevation to maximum height with a patient on the table.When the operating room group came in this morning, they lowered the table without issue and could not find anything wrong with the table.The biomedical engineer operated the table as well and could not find anything wrong either.Reporter stated that he would go back into the room and check the foot pedal again, stating that they had a foot switch cover on the foot switch at the time of the incident.Reporter states that he was not aware if they removed the patient off of the table last night while the table was elevated.The reporter states that the event occured during a procedure, which took place on (b)(6) 2018, and that the procedure was completed without any injury to patient or staff, also stating that the handswitch and floor switch were not touched.A follow-up call was made to the reporter on 14 september 2018, in which he states that he has ordered a table foot switch from a 3rd party vendor to replace theirs.He states that he was not able to reproduce the uncommanded movement situation and believes it might have happened because of the people using it, as their endo team was not as familiar with the room as the cysto team.He stated that he will not request an lf service fse to come to the site, and that he is replacing the footswitch just as a precaution.

• Brand Name: HUT EXT DR FINAL ASSY,ST,FPD
• Type of Device: HUT EXT DR FINAL ASSY,ST,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 Key: 7952681
• MDR Text Key: 123534480
• Report Number: 1518293-2018-00037
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414008
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/10/2018
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1