MAUDE Adverse Event Report: SIEMENS AG MEDICAL SOLUTIONS SOMATOM DEFINITION; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 07740769

Device Problems Power Conditioning Problem (1474); Loss of Power (1475); Environmental Compatibility Problem (2929)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

Siemens was notified on (b)(6) 2014, via third party service provider, that the transformer caught fire and burned the cabinet at the customer site.Reportedly, the hospital facility experienced a power outage and the generator became active.The technician went to check the system and noticed smoke, then saw flames that were approx four (4) to ten (10) inches high coming from both sides of the transformer and spread to the bottom of the cabinet.A fire extinguisher was used to put out the fire.There was no pt involvement nor injury to hospital personnel reported.

Manufacturer Narrative

Siemens has forwarded multiple requests to the third party service provider to return the parts in question and to provide more detailed info in regard to the circumstances surrounding the event and the actions taken to restore the system to working order.The parts and the requested info have not been received, to date.Should the parts and the info become available for further investigation, a supplemental report will be submitted upon completion.Siemens became aware of the reported event on (b)(4) 2014.

• Brand Name: SOMATOM DEFINITION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS AG MEDICAL SOLUTIONS; 51 valley stream pkwy.; ms - d02; malvern PA 19355
• Manufacturer Contact: marlynne galloway ; 51 valley stream pkwy.; ms - d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 4017261
• MDR Text Key: 4876035
• Report Number: 2240869-2014-05604
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07740769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2014
• 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: TRANSFORMER