MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM SENSATION 64; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED, PRODUCT CODE: JAK

Model Number 8377520

Device Problems Loss of Power (1475); Device Inoperable (1663)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 04/30/2015

Event Type  Injury  

Event Description

The customer notified siemens on (b)(6) 2015 that during a lung biopsy the ct scanner went down and an ultrasound machine was brought in and used to visualize the instrument that was still in the patient.Subsequently, the doctor was stuck with a needle tainted with the hepatitis c virus.There is no other information available as to the status of the doctor.There is no report of injury or mistreatment to the patient.

Manufacturer Narrative

Siemens became aware of the reported event on (b)(6) 2015 and this mdr is being mailed on (b)(6) 2015.Siemens' customer service engineer installed replacement parts (das controller board, dms power cables and the dms backplanes left/right) that resolved the reported issue of intermittent scan errors.Logs were examined and patient cases were observed without incident.The system is operational and further follow-up has confirmed that there have been no new occurrences since part replacements were installed.Considering this, no further corrective action is initiated.

• Brand Name: SOMATOM SENSATION 64
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED, PRODUCT CODE: JAK
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; 1 siemensstrasse; forchheim 9130 1; GM 91301
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 1 siemensstrasse; forchheim 9130 1; GM 91301
• Manufacturer Contact: marlynne galloway ; 51 valley stream pkwy.; malvern, PA 19355 ; 6102195361
• MDR Report Key: 4833648
• MDR Text Key: 15841870
• Report Number: 2240869-2015-12086
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 05/08/2015

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: Other
• Device Model Number: 8377520
• Device Catalogue Number: 54923
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 06/05/2015
• 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
• Treatment: SW VERSION: VB40B; DMS PACKPLANES LEFT/RIGHT; DMS POWER CABLES; DAS CONTROLLER BOARD
• Patient Outcome(s): Other