MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS AGIE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I

Model Number 10502200

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2015

Event Type  malfunction  

Event Description

During an esophogram procedure on the axiom luminos agile unit the pt was tilted to approx 90 degrees.In the process of retilting the table, the footrest unattached from the table at approx 45-60 degree angle and the pt slid off the table to the floor.The pt bumped her head twice during the fall, once on the table and then on the floor.The pt was immediately examined by a physician and a nurse.No injuries were identified; no medical intervention was required.

Manufacturer Narrative

Siemens local svc engineer was dispatched to the site.The engineer examined the system and the footrest.He was unable to find any issue with the footrest as it properly latched in place at all positions.The customer was recommended to ensure that the footrest was securely attached prior to any pt treatment.The concerned footrest was sent to the factory for further investigation.The system was returned to the customer for further use.The reported issue is under investigation and a supplemental report will be submitted once add'l info has been rec'd.

Manufacturer Narrative

The investigation of the returned footrest did not show any defects regarding functionality and reliability of the footrest.Moreover no damage or abnormalities could be determined and therefore the footrest works as specified.It is assumed, that the footrest fell off as it was not properly attached by the user.Correct attachment of the footrest is described in the operator manual xpd1-320.620.01.02.02, register 8, page 73/74.The footrest was replaced at the concerned customer site.

• Brand Name: AXIOM LUMINOS AGIE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; ms d-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4845211
• MDR Text Key: 20144315
• Report Number: 2240869-2015-12618
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10502200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR