MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVITY CONTOUR TRACK SYSTEM; APRON, LEADED

Model Number ZGCH

Device Problems Contamination /Decontamination Problem (2895); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Monorail screw covers falling into sterile field.Model: zgch.Serial#: (b)(4).Manufactured 2013.

Manufacturer Narrative

Device evaluated by mfr: device evaluation is expected, but not yet performed.This event was initially reported to the distributor, biotronik.It was reported that the screw covers on the rail were falling into the sterile field.There was no patient or caregiver injury reported as a result of this event.The unit has been taken out of use, currently.This is the first reported complaint of this type, based on historical complaint data review.The screw covers are specific to this zero gravity model, which has been discontinued.The root cause is unknown at this time.The original malfunctioning component is being requested to be returned for evaluation, but has not been received.Device evaluation by the technician for servicing has not yet been completed.Per the instructions for use (ifu) ¿a thorough inspection of equipment should be performed, after each service call, prior to releasing the equipment for use.¿ additionally, ¿the zero-gravity system requires annual preventative maintenance, inspection, and general cleaning throughout its life.¿ manufacturer reference file (b)(4).

• Brand Name: ZERO GRAVITY CONTOUR TRACK SYSTEM
• 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: 16259759
• MDR Text Key: 308585246
• Report Number: 2182318-2023-00001
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2023

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: ZGCH
• Device Catalogue Number: ZGCH
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1