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

Model Number 10762472

Device Problem Unintended System Motion (1430)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 03/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens local service engineer checked the concerned unit.The footrest and the locking mechanism were both in order and no fault could be determined.It is assumed that the footrest might have not been properly attached to the table.The operator manual requests that daily tests are carried out, including re-attachment the footrest to ensure that it is attached correctly (xpd1-320.620.01.02.02, chapter 8, pages 73/74).This report was submitted april 8, 2016.

Event Description

Siemens became aware of an injury that occurred during an examination on the luminos agile max system.When the patient table was in vertical position with a patient standing on the footrest, the footrest fell down on the physician, who was standing in front of the patient.It was reported that the physician had to go for an x-ray.The physician's big toe was broken and his foot had to be placed in a boot.No other injuries were reported in this case.

• Brand Name: LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS GMBH; henkesstrasse 1; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 5564576
• MDR Text Key: 42333628
• Report Number: 2240869-2016-36662
• 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
• Report Date: 03/11/2016

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: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/08/2016
• 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