MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH SIEMENS LUMINOS AGILE SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10409010 SYSTEM IVK

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Anxiety (2328)

Event Date 09/29/2015

Event Type  malfunction  

Event Description

Patient was on fluoroscopy table.Table was being lowered slowly by the radiology tech.Table made an unusual, loud noise as it was being lowered.Patient said that the table dropped suddenly to the floor.Staff in room said that table lowered slowly, did not drop suddenly.Staff observed that pt became startled when the table made a noise and the patient moved when she became startled.Patient complained of back pain after she got off of the table.The hospital's clinical engineering dept was contacted to evaluate the table following this event.

• Brand Name: SIEMENS LUMINOS AGILE SYSTEM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty blvd.; malvern PA 19355
• MDR Report Key: 5115623
• MDR Text Key: 27216520
• Report Number: 5115623
• 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: Other
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10409010 SYSTEM IVK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• 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
• Treatment: NO
• Patient Age: 51 YR
• Patient Weight: 79