MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRVTY FLR SYSTM 6.5' ARM; APRON, LEADED

Model Number	ZGM-6-5H
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Device Handling Problem (3265)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Cramp(s) /Muscle Spasm(s) (4521)
Type of Reportable Event	Serious Injury
Event or Problem Description
2 staff members got injured trying to move a zg floor system.The 2 employees have no experience with zero gravity and attempted to move the system without the appropriate training according to the contact at the hospital.The system hasn't been used for quite some time so there is a lack of knowledge on how to move and use the device.There were no reports of the system being defective.Employee 1 sustained a serious toe injury due to the system rolling/pushed over her toe.The 2nd employee sustained a calf strain trying to push the zero gravity.Butler was informed that tidi would send someone there to do an in-service and train them how to move and opertate the system.
Additional Manufacturer Narrative
The complaint reports 2 staff members got injured trying to move a zg floor system.The 2 employees have no experience with zero gravity and probably shouldn't have attempted to move the system without the appropriate training.The system hasn't been used for quite some time so there is a lack of knowledge on how to move and use the device.There were no reports of the system being defective.Employee 1 sustained a serious toe injury due to the system rolling/pushed over her toe.The 2nd employee sustained a calf strain trying to push the zero gravity.This is the first reported complaint of this type, based on historical complaint data review.Per the tidi zero gravity sales consultant, training was provided to the staff on (b)(6) 2025.No documentation of the training has been provided as of yet.Per the instructions for use (ifu): warning! tip over hazard lower assembly to lowest height prior to transport.Warning! tip over hazard.To relocate device in surgical suite: raise leveling feet; roll over flat surfaces with no obstructions.Within the surgical suite or to other rooms.The floor unit may be moved to other rooms if disassembly is not required.If disassembly is required, contact tidi products service.1.Raise leveling feet and unlock casters.2.Carefully push base, using handles, over flat surface with no obstructions.3.Level the base according to this document.Service issues are trended and reviewed by management on a monthly basis.As part of this monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time manufacturer reference file: (b)(4).

• Brand Name: ZERO GRVTY FLR SYSTM 6.5' ARM
• Common Device Name: 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: 22378223
• Report Number: 2182318-2025-00067
• Device Sequence Number: 8025842
• Product Code: EAJ
• UDI-Device Identifier: 00618125176250
• UDI-Public: 00618125176250
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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 Model Number: ZGM-6-5H
• Device Catalogue Number: ZGM-6-5H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown