MAUDE Adverse Event Report: MAVIG GMBH MONITOR SUSPENSION SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number GD60

Device Problems Component Falling (1105); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 10/21/2015

Event Type  malfunction  

Event Description

Facility experienced failure of the mavig boom.Boom failed and fell- there was potential for catastrophic injury.A safety inspection has been requested to determine if a safety kit is needed.Have been unable to determine from siemens why the safety inspection by mavig has been denied.

• Brand Name: MONITOR SUSPENSION SYSTEM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): MAVIG GMBH; 25 hytec circle; rochester NY 14606
• MDR Report Key: 5415826
• MDR Text Key: 37620464
• Report Number: 5415826
• Device Sequence Number: 1
• Product Code: JAA
• 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: Patient
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GD60
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1