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

Model Number 10762472

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is on-going as the reported issue could not be reproduced by our technical experts.The log files were requested for further analysis.A supplemental report will be submitted if additional information becomes available.

Event Description

Siemens became aware of unintended system movement of the luminos agile max device.The digital imaging tower (dit) moved without control in longitudinal direction.There are no injuries attributed to this event.

Manufacturer Narrative

The complaint was investigated with the following result.The provided log files were analyzed and no problem was identified.The log files showed that all system movements were controlled by the operator.The reported issue could not be reproduced by siemens technical experts.The system was checked and it works as specified.The dit movement was found to have an excellent response, initiating very slow to more forceful movement according to design.According to information provided by local service organization, only one operator encountered the reported issue.Covers on both sides of the dit are equipped with safety switches in order to prevent all unintended movement in longitudinal direction.The movement is stopped immediately when an obstacle is touched.No system failure or malfunction could be identified.

• Brand Name: UMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8459688
• MDR Text Key: 140164759
• Report Number: 3004977335-2019-74531
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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: 03/19/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other