MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ONCOR AVANT GARDE; ACCELERATOR, LINEAR, MEDICAL

Model Number 05863472

Device Problem Device Slipped (1584)

Patient Problem Head Injury (1879)

Event Date 01/31/2014

Event Type  Other  

Event Description

Siemens was notified on (b)(6) 2014 that when an md went into the treatment room to position a pt the md hit their head on the collimator.When the md bent down the cone slid out of its hold, hit the md's head and then hit the pt's lip.Reportedly, when the cone was inserted they heard normal movement.The gantry was positioned at 315 degrees and the collimator was positioned at 40 degrees when the md hit his head on the collimator.

Manufacturer Narrative

Siemens became aware of the reported issue on (b)(4) 2014.Siemens' investigation into the reported incident is ongoing.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: ONCOR AVANT GARDE
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 757a arnold drive; martinez CA 94553
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 757a arnold drive; martinez CA 94553
• Manufacturer Contact: marlynne galloway ; 51 valley stream parkway; ms-d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 3688167
• MDR Text Key: 4299674
• Report Number: 2910081-2014-00956
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05863472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONE