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

Model Number 7000DV

Device Problems Unintended Movement (3026); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Event Description

Anesthesia staff pressed the control button to move the bed into reverse trendelenberg position intraoperatively, the bed made a very loud cracking noise and suddenly dropped about an inch with the patient on it.The immediate area was inspected, no obstructions to bed movement found.The bed subsequently resumed normal operation.No harm to the patient.

• Brand Name: TRUSYSTEM
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): TRUMPF MEDICAL SYSTEMS, INC. (HILL-ROM, INC.); 1046 legrand blvd.; charleston SC 29492
• MDR Report Key: 8252270
• MDR Text Key: 133218941
• Report Number: 8252270
• Device Sequence Number: 1
• Product Code: JAE
• 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: 01/07/2019

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
• Device Operator: Health Professional
• Device Model Number: 7000DV
• Device Lot Number: 102787453
• 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: 01/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1