MAUDE Adverse Event Report: TIDI PRODUCTS, LLC ZERO-GRAVITY; APRON, LEADED

Model Number ZGM-6-5H

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Head Injury (1879)

Event Date 07/29/2016

Event Type  malfunction  

Event Description

Zero gravity suspended radiation protection device broke during ablation procedure.Patient was on table and the device fell into doctor, hitting him in the head and the weight of lead device falling on both arms and shoulders.Manufacturer response for lead apron, zero gravity (per site reporter): they replaced the unit and took ours back.

• Brand Name: ZERO-GRAVITY
• Type of Device: APRON, LEADED
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 14241 n. fenton rd.; fenton MI 48430
• MDR Report Key: 6169401
• MDR Text Key: 62217881
• Report Number: 6169401
• Device Sequence Number: 1
• Product Code: EAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/24/2016

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: ZGM-6-5H
• Other Device ID Number: 559430-L-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1