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

Model Number ZGM-6-5H

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

5/16/23- the swivel assembly is rusted.Model: zgm-6-5h serial#: (b)(6) manufactured 2017.

Manufacturer Narrative

H10: device is unavailable to be returned for evaluation.Therefore, this report is based on customer provided information only.It was reported that there was rust on the swivel assembly.Images were provided showing rust and flaking, peeling outer coating at the location where the boom arm attaches to the base or stand portion of the unit.This was identified as being in a location where dust or debris from the corrosion could fall and enter into the sterile field.The customer was contacted for more information on cleaning practices used at the facility, what solution was being used, if the device had been involved in any collisions that could have damaged the outer coating, etc., but no additional information was received.The customer has reported that they will no longer be using the zero gravity system and the unit will be scrapped.Per the user guide (instructions for use), "zero-gravity must be thoroughly cleaned and disinfected in accordance with standard operating room practices.Clean each component after use and prior to maintenance.Clean metal surfaces with mild detergent at manufacturer¿s recommended strength, in warm water.A 10% household chlorine bleach solution in warm water may be used for disinfection.Use only soft wiping materials.Never use rough or abrasive-faced sponges, steel wool, brushes, or cleaning pads.Never use scrapers or metal tools of any kind." at this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.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).

• Brand Name: ZERO GRAVTY 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: 17100955
• MDR Text Key: 317827849
• Report Number: 2182318-2023-00050
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/15/2023

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 Catalogue Number: ZGM-6-5H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/09/2023
• 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