MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG TRUMPF MEDICAL; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 108731515

Device Problems Entrapment of Device (1212); Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

During incision and drainage procedure, the bed was adjusted by the anesthesiologist and the scrub tech's mayo stand became wedged under the locking device of the robotic bed.This caused irrigation fluids to be dropped off the sterile field onto the floor.When the tech attempted to pull the mayo stand from where it was wedged, the entire bed began to move.The bed was checked and was locked during this.Writer was able to go under the table and push the bed while the tech pulled the mayo stand to dislodge it and stabilize the bed.After, the bed was checked again and was locked.

• Brand Name: TRUMPF MEDICAL
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16378223
• MDR Text Key: 309571875
• Report Number: 16378223
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 108731515
• Device Catalogue Number: 1723633
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Female