MAUDE Adverse Event Report: TRUMPF MEDICAL TRUSYSTEM 7500 HYBRID PLUS (FC); SURGICAL TABLE

Model Number	1854087
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Issues with the hillrom - trumpf table.The trumpf table is unresponsive and not working correctly.Today, the hybrid staff elevated the table approximately 6 inches, the alarm went off, and the staff were unable to move the table.Eventually, they got the table to move very slightly using the hand control and the alarm stopped.Per email from reporter, neither vendor, siemens or trumpf, can confirm if the problem is on their side and are collaborating to make sure that it doesn¿t happen again.Per email from leader, it still happened and x2 and may be repeated in another facility and cause patient harm.Doctor even refused to use the room until investigated.It was significant enough to shut down our services.Manufacturer response for surgical table, trusystem 7500 hybrid plus (fc) (per site reporter): neither vendor, siemens or trumpf, can confirm if the problem is on their side and are collaborating to make sure that it doesn¿t happen again.

• Brand Name: TRUSYSTEM 7500 HYBRID PLUS (FC)
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): TRUMPF MEDICAL; 1046 legrand blvd.; charleston SC 29492
• MDR Report Key: 11093609
• Report Number: 11093609
• Device Sequence Number: 11821935
• Product Code: JEA
• UDI-Device Identifier: 00887761996045
• UDI-Public: (01)00887761996045(11)190702(240)1854087
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2020
• Report Date (Section F): 12/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1854087
• Device Catalogue Number: 1854087
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 114
• Date Report Sent to FDA: 12/14/2020