MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U; SURGICAL TABLE

Model Number 1723633

Device Problem Circuit Failure (1089)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

Upon inspection it was identified a circuit board was defect.The circuit board was exchanged and the device is working as intended.If further information will become available during investigation a follow-up report will be provided.

Event Description

The customer alleged an error message was displayed during a surgical procedure.Following this the user was unable to position the device any more (no functions available), even after a trying a reset and enabling the emergency operation.No harm or significant impact to the procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 13203901
• MDR Text Key: 290973581
• Report Number: 3007143268-2022-00001
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1723633
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1