MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVITY; ZERO GRAVITY FLOOR SYSTEM,

Model Number ZGM-6-5H

Device Problem Device Fell (4014)

Patient Problem Head Injury (1879)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, it was reported that there was an incident at the hospital where the entire body shield became detached during a procedure.No injuries were reported at that time.The apparent cause was that the 4 bolts that suspend the body shield by the frame were not tight and the frame had migrated out of the clamp assembly.On 11/12/2021, additional information was received.It was then reported that the doctor was hit in the head by the bar holding the apron, though the extent of any injuries or whether any medical intervention was required were not provided.The facility had reported that they were completing an incident report, though this information was not shared with tidi upon request.The unit was quarantined and not available for use until biotronik/tidi came and physically inspected it, as per the healthcare facility administration.The system was purchased in (b)(4) of this year (2021).

Manufacturer Narrative

Summary: this report is based on the on-site inspection of the complaint unit and customer-provided information.Despite multiple attempts to obtain additional information, the extent of injury to the caregiver is not known at this time.Historical complaint review found that there have been no similar complaints for body shield falling due to loose bolts documented in the last 3 years.This device has a deft rate of 0.76% for this failure over that time period.On-site evaluation of the complaint unit by installer technician confirmed that lead shield fell out of the metal block due to the 4 bolts that hold it not being tightened adequately.Additionally, 3 bolts on top of the unit that hold the boom arm onto the unit, and end stop bolts were not tightened down or torqued to the specified requirement.An investigation has been opened internally to determine root cause and corrective actions and is currently in process.There are 2 possible root causes identified at present: body shield not secured during installation and body shield not secured after post-installation move.The installer was unable to provide evidence of bolts being tightened at the point of install and the customer has denied moving or reassembling the unit.The product instructions for use were reviewed and found to provide adequate instructions for performing the task of tightening the bolts a part of the installation or re-assembly after moving the unit.However, the ifu is being reviewed for updates to potentially prevent tech-level work being performed by non-approved technicians (such as hospital staff) going forward.Manufacturer reference file # (b)(4).

Manufacturer Narrative

Summary: this report is based on the on-site inspection of the complaint unit and customer-provided information.Despite multiple attempts to obtain additional information, the extent of injury to the caregiver is not known at this time.Historical complaint review found that there have been no similar complaints for body shield falling due to loose bolts documented in the last 3 years.This device has a deft rate of 0.76% for this failure over that time period.On-site evaluation of the complaint unit by installer technician confirmed that lead shield fell out of the metal block due to the 4 bolts that hold it not being tightened adequately.Additionally, 3 bolts on top of the unit that hold the boom arm onto the unit, and end stop bolts were not tightened down or torqued to the specified requirement.An investigation has been opened internally to determine root cause and corrective actions and is currently in process.There are 2 possible root causes identified at present: body shield not secured during installation and body shield not secured after post-installation move.The installer was unable to provide evidence of bolts being tightened at the point of install and the customer has denied moving or reassembling the unit.The product instructions for use were reviewed and found to provide adequate instructions for performing the task of tightening the bolts a part of the installation or re-assembly after moving the unit.However, the ifu is being reviewed for updates to potentially prevent tech-level work being performed by non-approved technicians (such as hospital staff) going forward.Manufacturer reference file # (b)(4).

Event Description

On (b)(6) 2021, it was reported that there was an incident at the hospital where the entire body shield became detached during a procedure.No injuries were reported at that time.The apparent cause was that the 4 bolts that suspend the body shield by the frame were not tight and the frame had migrated out of the clamp assembly.On (b)(6) 2021, additional information was received.It was then reported that the doctor was hit in the head by the bar holding the apron, though the extent of any injuries or whether any medical intervention was required were not provided.The facility had reported that they were completing an incident report, though this information was not shared with tidi upon request.The unit was quarantined and not available for use until biotronik/tidi came and physically inspected it, as per the healthcare facility administration.The system was purchased in june of this year (2021).

• Brand Name: ZERO GRAVITY
• Type of Device: ZERO GRAVITY FLOOR SYSTEM,
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprose drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 12980407
• MDR Text Key: 285466007
• Report Number: 2182318-2021-00013
• Device Sequence Number: 1
• Product Code: EAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2021

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 Model Number: ZGM-6-5H
• Device Lot Number: 640644
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/10/2021
• 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: Unknown
• Patient Sequence Number: 1