MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS ZEE CEILING; SYSTEM, XRAY, ANGIOGRAPHIC

Model Number 10094137

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Discomfort (2330); Injury (2348)

Event Date 09/11/2014

Event Type  Injury  

Event Description

It was reported that a customer rotated the c-arm of the artis zee system to a different angulation and the side of the flat detector collided with the patient's face.The patient suffered a bloody nose and was treated with first aid by the attending physician.

Manufacturer Narrative

Siemens initiated an investigation into the reported event.The event was classified as a safety compliant, however, there was no indication of a system malfunction and the event most likely occurred because of a user error.Upon investigation, the fd guard was found to be operating as designed.Several attempts were made to obtain additional information and details from the customer site, however, no further information was received.In the abundance of caution, siemens has made the determination to report this event as an mdr.

• Brand Name: ARTIS ZEE CEILING
• Type of Device: SYSTEM, XRAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; malvern PA 19355 140
• Manufacturer (Section G): SIEMENS AG, AX QM
• Manufacturer Contact: meredith adams ; 51 valley stream pkwy.; malvern, PA 19355-1406 ; 6104483237
• MDR Report Key: 4404506
• MDR Text Key: 5128686
• Report Number: 2240869-2014-07459
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/26/2014

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: 10094137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 85 YR