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

Model Number 10762472

Device Problem Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is on-going.A supplemental report will be submitted if additional information becomes available.

Event Description

Siemens became aware of issues with a table on the axiom luminos agile max unit.It was reported that the table abruptly stops while being tilted or raised.It was also reported that the table lowered down until the tube touched the floor without given command by operator.There is no patient involvement in this case.No injuries are attributed to this even.(b)(6).

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/19.The issue was investigated in detail.The investigation showed that the brakes of the lift drive were not activated after movement.During start of any movements the brakes will be released.After deactivation of any movements the brakes will be engaged.In this case the lift drive was activated and after the deactivation the brake did not engage (as specified).The table moved downwards by itself since the weight of the table cannot be stopped by the gear.The movement of the table is a slow, not motorized, movement to the floor.It was found that the interface board cdbe was defective which caused this issue.After replacing this affected component the problem did not reoccur.The spare part consumption of the concerned interface board cdbe (material number 10656098) shows values that are below the defined threshold.No general problems and also no failure clusters regarding this kind of defect are known.

• Brand Name: AXIOM LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 7558002
• MDR Text Key: 109759702
• Report Number: 3004977335-2018-30569
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2018
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other