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

Model Number ZGCM-66

Device Problems Component Falling (1105); Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2016

Event Type  malfunction  

Event Description

This incident was not made known to us until ~ two weeks ago.No patient involved.Incident involved a doctor using a zero-gravity overhead suspended radiation shielding system.The mechanical suspension means of the radiation shielding element ceased to hold up that component (root cause to be determined), resulting in it falling.The flexible shoulder shields glanced off the doctor's arms as it fell.The doctor reports that he was not injured.

• Brand Name: ZERO-GRAVITY
• Type of Device: RADIATION PROTECTION 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 ; 8105933232
• MDR Report Key: 5912773
• MDR Text Key: 54278923
• Report Number: 1825560-2016-00002
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/25/2016

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-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 82