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

Model Number 10762472

Device Problem Break (1069)

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

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

The concerned system was checked by siemens local service engineer.New foot board for the system was ordered.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.

Event Description

It was reported that a foot board broke off the luminos agile max unit during an examination.A patient was standing on the board when it broke; however, no injuries were reported in this case.

Manufacturer Narrative

The investigation of the reported issue was completed by siemens factory experts.The investigation of the foot board showed defective guiding rail, which indicates collision with the floor.The detent mechanism and the locking bolts of the foot board were checked and found to be within specifications.The foot board was slightly bent, however, this had no impact on device functioning and safety.No other safety concerns or malfunctions were found.The incorrect locking of the foot board might have been caused by improper use or failure to follow locking instructions.This could have caused the foot board to shift and result in collision with the floor during system tilt up leading to damage and fall of the foot board.The correct locking and handling of the foot board is described within operator manual xpd1-325.620.01.01.02, chapter 8.No failure of the system was determined.This report was submitted march 30,2017.

• Brand Name: LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forhheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forhheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd; mc 65-1a; malvern 19355 ; 6104486478
• MDR Report Key: 6326009
• MDR Text Key: 67594052
• Report Number: 2240869-2017-68860
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other