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

Model Number 10093961

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

It was reported that the footboard on the axiom iconos r200 system became dislodged and the patient fell off the table.The patient rec'd slight scratches on her hand.The x-ray images of the hand did not show any fractures.The patient did not require any medical treatment.The reported event occurred in (b)(6).

Manufacturer Narrative

The concerned footboard was requested to be returned for further investigation.The reported issue is under investigation and a supplemental report will be submitted once add'l info has been rec'd.This report was submitted (b)(4) 2014.(b)(6).

• Brand Name: AXIOM ICONOS R200
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE; 51 valley stream pkwy.; ms d02; malvern PA 19355
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forccheim 9130 1; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; ms d02; malvern, PA 19355 ; 6102194834
• MDR Report Key: 3700207
• MDR Text Key: 21968351
• Report Number: 2240869-2014-00576
• 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: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/21/2014

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: 10093961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR