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

Model Number ZGM-6-5H

Device Problem Material Integrity Problem (2978)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

Despite multiple attempts the product was not returned for evaluation.It was reported that the cable between the balancer and the body shield broke during an operation the body shield was reported to be damaged as a result of this event.This event was initally reported the german distributor biotronik se & co.Kg by a physician in germany.It was confirmed there were no resulting injuries to the patient or caregiver as a result of this event.Per the instructions for use (ifu) excessive rotation of the body shield may cause the balancer cable to break.The body shield must be lowered and allowed to unwind after each use, in an unlocked position.Annual inspections must be performed on the cable.Cables must be replaced if there are any signs of wear and / or abnormalites.The reporting hospital facility was unable to supply any maintenance records to support the occurrence of regular inspections.Historical complaints were reviewed, and there is no reported harm related to this malfunction.

Event Description

The cable between the balancer and body shield broke during an operation.No injuries were sustained as a result of this event.

• Brand Name: ZERO GRAVITY
• Type of Device: ZERO GRAVITY FLOOR SYSTEM
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• MDR Report Key: 11713424
• MDR Text Key: 264710560
• Report Number: 2182318-2021-00001
• Device Sequence Number: 1
• Product Code: EAJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/23/2021

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 Operator: No Information
• Device Model Number: ZGM-6-5H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/23/2021
• 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: Reuse
• Patient Sequence Number: 1