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

Model Number	1604788
Medical Device Problem Codes	Smoking (1585); Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During field investigation by a hillrom technician it was identified that one battery has started to burn.The battery was exchanged and the device is functioning as designed.Once additional relevant information is obtained from further investigation a follow-up report will be submitted.
Event or Problem Description
The customer reported that burning odor was coming from operating table.No injury or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Event or Problem Description
The customer reported that burning odor was coming from operating table.No injury or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The investigation identified an installation failure of the battery.Due to this incorrect installation a collision occurred between the battery and a metal part when the column was moved into the lowest position.This collision caused a damage to the battery housing and following a short circuit inside the battery.The battery was installed by the customer and no hillrom/trumpf medical employee or authorized service partner.The service manual of the operating table indicates clearly the correct installation procedure and to pay attention for the correct installation of the battery.Based on this no further action is necessary.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 11327186
• Report Number: 3007143268-2021-00003
• Device Sequence Number: 10968480
• Product Code: JEA
• UDI-Device Identifier: 00887761989030
• UDI-Public: 887761989030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/10/2021

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: 01/20/2021
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1