MAUDE Adverse Event Report: HILL-ROM, INC. (TRUMPF MEDICAL SYSTEMS, INC.) TRUMPF TRUSYSTEM TABLE 7000 DV; TABLE, RADIOLOGIC

Device Problems Unintended System Motion (1430); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

Event Type  malfunction  

Event Description

Patient was in lithotomy position and was being put in trendelenburg, the or table pad began sliding back toward the head of the bed.The bed was returned to level position to assess the padding situation.It was noted that the velcro strips had been replaced with new strips, but the plastic backing was not removed prior to returning the pad to the bedframe, therefore the velcro was not adhering.The plastic backing was removed, and the pads were attached properly by the velcro.The patient was reassessed for safety by the surgical and anesthesia team and it was determined that it was safe to proceed with surgery.No harm to the patient.

• Brand Name: TRUMPF TRUSYSTEM TABLE 7000 DV
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): HILL-ROM, INC. (TRUMPF MEDICAL SYSTEMS, INC.); 1046 legrand blvd.; charleston SC 29492
• MDR Report Key: 8925149
• MDR Text Key: 155338224
• Report Number: 8925149
• Device Sequence Number: 1
• Product Code: KXJ
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 08/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA