MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8098027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A technical investigation by siemens was not possible.The damaged parts are not in siemens possession and could not be sent back for investigation.A ups of this type is not released and shipped in combination with the siemens ct scanner.This type of ups is used with axa systems.Although it may have been purchased from siemens, it would not have been shipped in combination with the ct scanner.It is unknown if the ups was purchased from siemens or from its manufacturer, eaton.The technical investigation will be performed by eaton.No device malfunction of the siemens ct scanner has been reported.

Event Description

It was reported to siemens that the uninterruptible power supply (ups) was smoking in the cabinet.Reportedly, the fire department arrived onsite.Although there was no open fire, an injury was sustained due to the event.Medical intervention was necessary to treat the injured person (type of injury and medical treatment are unknown).Although requested, additional details were not provided to siemens.Based on the information provided to siemens, siemens has determined this incident may have resulted in negligible injury due to possible smoke inhalation.This report is being submitted with an abundance of caution.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, pa ; 4486484
• MDR Report Key: 9763801
• MDR Text Key: 192683847
• Report Number: 3004977335-2020-17733
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other