MAUDE Adverse Event Report: TIDI PRODUCTS, LLC TIDI PRODUCTS ZERO-GRAVITY; RADIATION SHIELD SYSTEM

Model Number ZGCM-HSA

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  malfunction  

Event Description

Body shield frame tube slipped out of the clamp block due to all four clamp bolts being loosened.The hospital reports that they did not loosen the four bolts, but tidi products believes that somehow those bolts had to have been loosened not long before the incident.The original installer report indicates that the bolts were tight at installation, the history of >400 other installations seems to indicate that the bolts will not loosen randomly or due to some other influence, and the behavior of the system is sufficiently different with the bolts loose that we are confident their loose status would have been noticed by users if it had persisted for long before the incident.Our working theory is that someone associated with the hospital may have loosened the bolts so as to remove the body shield for periodic fluoroscopic radiation-shield checking (i.E.State law requirement), then failed to fully re-tighten them upon re-hanging the body shield.Note that this means of fluoroscoping the body shield is contrary to the procedure detailed in the user manual.Coincidentally, tidi products' product representative (b)(6) was on his way to the hospital that day, and learned of the issue upon arrival.So, he properly re-installed the body shield with tightened bolts.Note that there was no cable breakage or other issue that might be related to cable issues.

• Brand Name: TIDI PRODUCTS ZERO-GRAVITY
• Type of Device: RADIATION SHIELD SYSTEM
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 14241 fenton road; fenton MI 48430
• Manufacturer (Section G): TIDI PRODUCTS, LLC; 14241 fenton road; fenton MI 48430
• Manufacturer Contact: john schaefer ; 14241 fenton road; fenton, MI 48430 ; 8107505300
• MDR Report Key: 6156892
• MDR Text Key: 62340935
• Report Number: 1825560-2016-00003
• 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: company representative
• Reporter Occupation: Service and Testing Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/02/2016

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: Physician
• Device Model Number: ZGCM-HSA
• Device Catalogue Number: ZGCM-HSA
• Device Lot Number: 575365
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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