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

Model Number 10093962

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

Siemens local service engineer was dispatched to the facility to inspect the system.The compression force is displayed on the remote control console and is limited to a maximum of 155 n forces by a safety switch.The compression unit is intended to compress soft tissues only.A supplemental report will be submitted if additional information becomes available.This report was submitted october 12, 2015.(b)(6).

Event Description

It was reported that during a gastrointestinal barium exam on the axiom iconos r200 system the compression unit was lowered onto the patient.The compression unit compressed the patient with more than 50n force causing a rib fracture.The patient was taken for a ct scan, during which a fracture of the 10th rib on the right side was identified.The patient was checked into the medical facility to receive a 3-day therapy for the injury.The reported event occurred in (b)(6).

• 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: 5144813
• MDR Text Key: 28043173
• Report Number: 2240869-2015-05090
• 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
• Report Date: 09/22/2015

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: 10093962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• 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
• Patient Age: 61 YR