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

Model Number 5902767

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens engineer inspected the system and determined that the rubber part of the wheel on the compression unit was completely destroyed.The compression unit was removed by the engineer and will be replaced.A supplemental report will submitted if additional information becomes available.(b)(6).

Event Description

During a regular patient exam (without use of compression unit) on the axiom iconos r200 system, the compression unit suddenly fell down on the table and landed close to the patient's arm.There are no injuries attributed to this incident.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens completed investigation of the reported issue.Analysis of the returned component showed that the surface of the plastic cover was damaged.The friction wheel was severed by external forces such as heavy parts falling on the compression unit.The bar did not show any abnormalities which could have resulted in damages to the friction wheels therefore, it is assumed that an unknown obstacle between friction wheel and the bar caused the damage.A previous security screening of friction wheels did not show any general or systematical issue.The system at the concerned customer site had been already fixed by local service.

• Brand Name: AXIOM ICONOS R200
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 5717143
• MDR Text Key: 48148783
• Report Number: 2240869-2016-43266
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5902767
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other