MAUDE Adverse Event Report: TRUMPF MEDICAL SYSTEMS, INC. TRUSYSTEM; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 7000DV

Device Problems Device Slipped (1584); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2020

Event Type  malfunction  

Event Description

Patient intubated in low lithotomy position.The black operating room mattress pad slid out about two inches toward anesthesia team.Trendelenburg reversed.Staff then noted that there was no velcro under the operating room bed to hold the black mattress pad in place.Velcro was located and placed on bed.Patient was transferred to a newly velcro bed.Procedure was then performed.

• Brand Name: TRUSYSTEM
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): TRUMPF MEDICAL SYSTEMS, INC.; 1046 legrand blvd.; charleston SC 29492
• MDR Report Key: 10217209
• MDR Text Key: 197113222
• Report Number: 10217209
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7000DV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Weight: 127