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 Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection it was noticed that the battery was installed incorrectly by the customer one month ago.This allowed a part of the operating table to collide with the battery and damaged the housing.Following an internal short circuit and a smoldering fire was the result of this damage.The service manual of the operating table indicates clearly the correct installation procedure and to pay attention for the correct installation of the battery.If new relevant information will become available during further investigation, a follow-up report will be submitted.
Event or Problem Description
The customer alleged smoke was coming from the around the column base during a surgical procedure.The patient was moved to another operating table to finish the case.No harm was reported in relation to this event.This report was filed in our complaint handling system as complaint # (b)(4).
Event or Problem Description
The customer alleged smoke was coming from the around the column base during a surgical procedure.The patient was moved to another operating table to finish the case.No harm was reported in relation to this event.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
During inspection it was noticed that the battery was installed incorrectly by the customer one month ago.This allowed a part of the operating table to collide with the battery and damaged the housing.Following an internal short circuit and a smoldering fire was the result of this damage.The service manual of the operating table indicates clearly the correct installation procedure and to pay attention for the correct installation of the battery.It is also stated within the user manual that all repairs must be done by a trained technician.This instruction was not followed for the battery exchange.Based on this information, no further action is required.

• 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
• MDR Report Key: 12224141
• Report Number: 3007143268-2021-00012
• Device Sequence Number: 14717765
• Product Code: GDC
• UDI-Device Identifier: 00887761989030
• UDI-Public: 887761989030
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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: No Information
• Device Model Number: 1604788
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1