MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. AXIOM LUMINOS TF; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INT.

Model Number 10093902

Device Problems Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problem Head Injury (1879)

Event Date 06/23/2014

Event Type  Injury  

Event Description

It was reported that either a corrugated hose or a cable holder on the axiom aristos tf system became loose and fell down from the ceiling on the operators head.Approximate weight of the corrugated hose holder is 0.42kg.The operator suffered from a concussion and received medical treatment at the facility.The extent of treatment is unknown.The operator was supposed to return for an additional examination two days after the injury to determine her readiness to go back to work.No other information was provided to siemens.

Manufacturer Narrative

The system was checked by a local siemens engineer who found that the swivel hanger for 3d cables had come down and it was hanging by the cables.The hangers were reinstalled and the system was brought back to specifications.This report was submitted (b)(4) 2014.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INT.
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; valley stream parkway, ms d-02; malvern PA 19355 140
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forchheim 9130 1; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 3964861
• MDR Text Key: 18367782
• Report Number: 2240869-2014-05362
• 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: 06/25/2014

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: 10093902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/17/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other