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

Model Number 10430603

Device Problems Output above Specifications (1432); Radiation Overexposure (3017)

Patient Problem Radiation Overdose (1510)

Event Date 03/04/2018

Event Type  malfunction  

Manufacturer Narrative

The root cause of the reported event is confirmed to be identical to a known issue that was previously communicated to the customer via urgent device correction (ct053/17/s) that explained the risk of unnecessary radiation exposure for head scans on p.A./a.P.Topograms using the caredose 4d algorithm.The customer communication strongly recommends a work around using topograms in lateral position for all head scans until a solution is deployed to correct the malfunction.The solution for this issue is planned to be released in the near future.

Event Description

Customer reported to siemens on march 7, 2018 that during a scan using the caredose 4d algorithm, additional dose was given to a (b)(6) boy weighing (b)(6) during a head scan on (b)(6) 2018.However, there is no report of injury to the patient.This reported issue occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION FLASH
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; siemens strasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; siemens strasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 7366732
• MDR Text Key: 103788468
• Report Number: 3004977335-2018-20630
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/23/2018,03/07/2018

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: Health Professional
• Device Model Number: 10430603
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2018
• Distributor Facility Aware Date: 03/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2018
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2240869-11/13/17-0029
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 12