MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1604788
Medical Device Problem Codes	Defective Component (2292); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The column controller board and pcb adapter keypad board were replaced and configured to resolve the issue.The device functioned as designed.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
Event or Problem Description
The customer alleged the keypad and remote functions were not working.No harm was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The customer alleged the surgical table failed on (b)(6) 2022, and operation via the remote control and column keypad was not possible.During the investigation it was found that there were no abnormalities in the event log that indicated a failure of the surgical table.Adjustments via the remote control and column keyboard was not permitted because the floor lock was disengaged.The table was disengaged with the unlock command from the remote control.Various driving movements were attempted, whereby the table displayed the flashing lock/unlock button to alert the customer to jack up (lock) the table.This was apparently ignored by the customer, who continued to try to operate the table with various drive commands, but without success, since the table was in an unlocked state and rejected drive commands.Only after the customer had pressed the lock button the table was jacked up and all drive commands worked as intended.Based on this information, no further action is required.
Event or Problem Description
The customer alleged the keypad and remote functions were not working.No harm was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 15239088
• Report Number: 3007143268-2022-00020
• Device Sequence Number: 11986828
• Product Code: GDC
• UDI-Device Identifier: 00887761989030
• UDI-Public: 887761989030
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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 Model Number: 1604788
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown