MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. CX-RU US QT AXIOM ARISTOS FX; SYSTEM, X-RAY, STATIONARY

Model Number 07414803

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Head Injury (1879)

Event Date 06/16/2014

Event Type  Injury  

Event Description

It was reported that a cable holder on the axiom aristos fx fell down on the operator's head during an examination.The cable holder fell down from the transverse rail.The operator suffered a small wound to his head.The cut was treated with medicinal alcohol at the facility.The operator continued working after the incident.The reported event occurred in (b)(6).

Manufacturer Narrative

The defective part was requested by the factory for further investigation.A supplemental report will be submitted once additional information becomes available.(b)(4).(b)(6).

• Brand Name: AXIOM ARISTOS FX
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC. CX-RU US QT; 51 valley stream pkwy.; ms d-02; malvern PA 19355 140
• Manufacturer (Section G): SIEMENS AG; 127 henkesstrasse; erlangen ; GM
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; ms d-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 3940870
• MDR Text Key: 4530641
• Report Number: 2240869-2014-05090
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013826
• 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: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 07414803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2014
• 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: 28 YR