MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SOMATOM SENSATION 4; SYSTEM, X-RAY, ROMOGRAPHY, COMPUTED

Model Number 7005502

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abrasion (1689); Injury (2348)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

Siemens was notified on (b)(4) 2014 that a pt scan had just begun when the pt's arm hit the plexi ring while the gantry was in motion.The plexi ring had started wrapping around the pt and the technician was able to immediately pull it away from the pt, then stopped the scan.The pt sustained cuts and abrasions; the technician was not injured.A physician came and attended to the pts wounds however it is not known what type of treatment was given and the status of the pt is not known.

Manufacturer Narrative

(b)(4).Siemens' investigation into the reported event is on-going.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: SOMATOM SENSATION 4
• Type of Device: SYSTEM, X-RAY, ROMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; ms d02; malvern PA 19355
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forchheim 9130 1; GM 91301
• Manufacturer Contact: marlynne galloway ; 51 valley stream pkwy.; ms d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 3829622
• MDR Text Key: 4403904
• Report Number: 2240869-2014-01485
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2014

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: 7005502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 05/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SW VERSION: VA47C