MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVTY LOW PROFILE BALNCR; APRON, LEADED

Model Number ZGLPB

Device Problem Material Integrity Problem (2978)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

Summary: device return for evaluation is expected, but not yet received by the manufacturer.This event was initially reported to the canadian importer biotronik canada by a medical professional in canada.It was reported that the cable between the balancer and the body shield broke while preparing the device for operation.There was no patient or caregiver injury reported as a result of this event.Historical complaints were reviewed, and there has been no reported harm related to this malfunction.The root cause is unknown at this time.The likely cause, based on a historical complaint data review, is that the cable broke as a result of the excessive rotation of the cable in a single direction.This unit was scheduled to have the balancer which holds the cable replaced as part of a preventive maintenance plan at the time of the reported malfunction, but the work had not yet been completed.The new balancer contains a swivel to prevent this type of malfunction from occurring.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 abnormalities.Manufacturer reference file: (b)(4).

Event Description

It was reported that "this morning we has an issue with the zero gravity system.The lead shield support cable snapped during a procedure.Fortunately, no one was injured during this failure.I have attached pictures of the arm with the cut cables.No one was wearing the lead screen when the cable broke.The radiology technologists were dressing the screen with sterile plastic covers when the incident occurred.It fell to the floor not landing on or hitting any personnel.This was performed before the patient procedure commenced.

Manufacturer Narrative

The returned unit was received and evaluated by quality.Confirmed that the returned body shield balancer connector contained the remnants of a broken cable.There was obvious torsional loading indicated by individual wires versus a strand of wire.Sheathing bulging at the point of break within the cable and discoloration at the point of the break.This is a known hazard of cable break due to localized tensile loads on the individual cable wires due to torsional loading of the entire cable from cumulative rotation of the body shield about the cable axis.There has been a design enhancement to the body shield balancer connector design, and it has been updated to include a swivel.This will improve the user experience to prevent the torsional loading on the cable.This was an original body shield balancer connector, not the new swivel.This unit was scheduled to be replaced as part of an in-process preventive maintenance program at the time the failure was reported.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 abnormalities.Historical complaints were reviewed, and there is no reported harm related to this malfunction.No corrective or preventive actions are required at this time.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).

Event Description

Supplemental medwatch being sent for additional information.

• Brand Name: ZERO GRAVTY LOW PROFILE BALNCR
• 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: 15816128
• MDR Text Key: 307687891
• Report Number: 2182318-2022-00130
• 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: Foreign,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

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 Operator: Health Professional
• Device Model Number: ZGLPB
• Device Catalogue Number: ZGLPB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1