MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH SOMATOM SENSATION 64; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Device Inoperable (1663); Failure of Device to Self-Test (2937); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2017

Event Type  malfunction  

Event Description

Ct technicians came in and found this ct did not have any power and they had a biopsy that was scheduled.Technician went up to ct and found all power switches on the in-line power conditioner were turned off.Flipped those back on and ct still did not have any power.Found the image reconstruction computer turned off as well.Ensured all parts of the system were turned on and booted up.The system would not pass self test and crashed.Shut everything down again and rebooted.This time the unit came up and passed all self tests and boot up procedure.There was no patient harm involved, just delay in service.

• Brand Name: SOMATOM SENSATION 64
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 6529233
• MDR Text Key: 73932375
• Report Number: 6529233
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2017
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1