MAUDE Adverse Event Report: SIEMENS HEALTHINEERS COMPUTED TOMOGRAPHY SOMATOM DEFINITION FLASH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10430603

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 04/29/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens conducted a thorough investigation of the reported events.The root cause of the malfunction was determined to be a data transmission error caused by a broken data link connection.No other general product issues were detected.The replacement of the dascon board by siemens personnel solved the product malfunction, and no further remedial measures were required.No medical intervention was required for the 3 year old child that had been rescanned, and no further negative health consequences for the child were reported upon our request.Resubmission of initial report due to report code error.

Event Description

It was reported to siemens that a malfunction occurred on (b)(6) 2018, while operating a somatom definition flash, and a (b)(6) year old child was rescanned.There was a technical malfunction of the ct scanner (somatom definition flash), and it became necessary for the 3 year old child to be rescanned.

• Brand Name: SOMATOM DEFINITION FLASH
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS COMPUTED TOMOGRAPHY; siemenstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS COMPUTED TOMOGRAPHY; siemenstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 8491102
• MDR Text Key: 141184663
• Report Number: 3004977335-2018-28489
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other