MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ICONOS R200; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 5902767

Device Problems Unintended System Motion (1430); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal complaint id (b)(4).

Event Description

Siemens became aware on an incident with the compression unit on the axiom iconos r200.The mounting arm of the compression unit became loose and moved with fast speed to towards the ground.According to local service organization, the compression wheel was found to be broken.There are no injuries associated with this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The results of the investigation showed that the friction wheel of the compression unit had been damaged leading to the drop of the compression unit.The replaced friction wheel was requested for investigation, however, it was no longer available.Therefore, a deeper analysis of the part was not possible.The provided pictures indicate that an object between the tomo rod and the friction wheel caused damage to the wheel.The age of the part may have had an additional impact on the degree of damage.Siemens is not aware of similar events.The reported issue at the concerned facility was resolved by replacing the defective part.According to the maintenance instructions xpd3-340.831.20.07.02, chapter: 5.2.10 column longitudinal drive / option: compression, checking the friction wheel, the compression should be regularly checked.

• Brand Name: AXIOM ICONOS R200
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8708217
• MDR Text Key: 207333275
• Report Number: 3004977335-2019-82441
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K992660
• 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: 06/09/2019

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: 5902767
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other