MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVITY FLOOR SYSTEM 6.5' ARM; APRON, LEADED

Model Number ZGM-6-5H

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

H3 summary: this event was initially reported to the distributor, (b)(4).The incident was reported on march 22, 2024.A service technician was onsite on march 25, 2024 to evaluate the unit, and found that there is a component that has become broken.It is unknown when the component actually failed.Pictures provided to the manufacturer by the technician clearly show that the stop block, which is mounted on the top block assembly, has been struck by something with excessive force, severing one of the 2 bolts.The technician reported that the zero gravity unit functioned per oem specifications, with the exception of the over-rotation, due to the stop block failing and allowing the boom to pass over where the stop block should be installed.The purpose of the stop block and rubber bumper is to prevent the boom arm from rotating 360 degrees.It is believed that the damaged stop block allowed the boom to rotate past the safety point, which shifted the center of gravity, thus allowing the zero gravity unit to tip over towards the person that was pulling the system.Images provided depict some cosmetic deep scratches in the powder coating on the top block assembly, which would indicate a collision with some other device or object in or around the lab.The instructions for use were reviewed.Per the instructions for use (ifu) ¿the floor unit may be moved to other rooms if disassembly is not required.If disassembly is required, contact tidi products service.¿ additionally, the user is instructed to lock the boom arm in place before attempting to move the zero gravity.There is a stop block with a latching lock assembly opposite the one that broke that allows the boom arm to lock 90 degrees to the left of the center operating point.The boom cannot over rotate if locked properly, drastically reducing the risk of tipping.Despite finding that the instructions for use provide adequate instructions and warnings for the safe and effective use of the device, we have taken this opportunity to update them for better clarification of the steps needed for movement of the device to help further mitigate this risk of the unit tipping.At this time, there is no evidence that a manufacturing nonconformity contributed to the reported event.We will continue to monitor for this type of event going forward.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference file (b)(4).

Event Description

Zero gravity mobile system tipped over.The exact date is currently unknown.Information was provided by the distributor, biotronik.This is the first incident; the system tipped over injuring / breaking a lady's foot when moving the unit.The second incident occurred when the unit began to tip over, however it was caught by the person moving the system and did not fully fall over.No injuries were reported for the second incident.

• Brand Name: ZERO GRAVITY FLOOR SYSTEM 6.5' ARM
• Type of Device: APRON, LEADED
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 19149317
• MDR Text Key: 340673851
• Report Number: 2182318-2024-00055
• Device Sequence Number: 1
• Product Code: EAJ
• UDI-Device Identifier: 00618125176250
• UDI-Public: 00618125176250
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZGM-6-5H
• Device Catalogue Number: ZGM-6-5H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1