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 Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

Broken cable and associated balancer were returned to tidi products at the (b)(6) location on tuesday (b)(6) 2019.The returned product was decontaminated and disassembled and then sent to the contract manufacturer.The product complaint was confirmed as a broken cable.Currently this complaint is under investigation to determine the root cause.There have been no associated complaints for cable breakage for this product code in the past two years; this does not indicate a trend for this malfunction.

Event Description

Balancer body shield cable broke following the completion of a procedure.No patient or caregiver injury.

• Brand Name: ZERO GRAVITY
• Type of Device: ZERO GRAVITY FLOOR SYSTEM
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer (Section G): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 9236116
• MDR Text Key: 196410855
• Report Number: 2182318-2019-00006
• 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: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZGM-6-5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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