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

Model Number 10762472

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

The foot rest was requested for further analysis.The investigation is still ongoing.A supplemental report will submitted if additional information becomes available.

Event Description

It was reported that a footrest on the luminos agile max unit broke off with a patient standing on it.There are no injuries related to this event.

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.The provided photos were examined.On the picture it could be seen that the lateral guide bar of the foot rest was damaged.This damage indicated that the foot rest was not properly attached by the operator.Therefore, the foot rest shifted and fell down when the system was tilted.The correct attachment and handling of the foot rest is described in the operator manual (see ga xpd1-325.620.01.01.02 chapter 8, page 28/29 - footrest).No system malfunction was identified in this case.

• Brand Name: LUMINOS 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: 8524355
• MDR Text Key: 145915212
• Report Number: 3004977335-2018-48469
• 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
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

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
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 11/13/2018
• 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