MAUDE Adverse Event Report: SIEMENS HEALTHCARE AXIOM SIRESKOP SD; IMAGE-INTENSIFIED FLUOROSCOPIC SYSTEM

Model Number 8890415

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 12/19/2013

Event Type  malfunction  

Manufacturer Narrative

An in-house engineer and a local siemens engineer test the concerned footboard and were unable to find any issues or damages.A spare was ordered for replacement and the exchanged part was requested by our factory for further investigation.The procedure for attaching the footboard to the system is described in detail in the operator manual axd1-240.621.13.01.02.The reported issue is under investigation and a supplemental report will be submitted once additional information has been received.

Event Description

It was reported that the footboard on the axiom sireskop sd system became dislodged and the patient slipped off the table.The footboard became loose during the table tilt.The physician was able to catch the patient.There are no injuries reported in this event.The operator, who mounted the footboard, stated that the footboard had been checked for proper installation before the exam.

• Brand Name: AXIOM SIRESKOP SD
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE; 51 valley stream parkway, ms d02; malvern PA 19355
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forccheim 9130 1; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream parkway, ms d02; malvern, PA 19355 ; 6102194834
• MDR Report Key: 3788159
• MDR Text Key: 22208064
• Report Number: 2240869-2014-11567
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2013

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: 8890415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/13/2014
• 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