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

Model Number 10742326

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

Patient Problem Radiation Overdose (1510)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation has shown that the root cause of the reported event has been identified as a known software bug in the option "care dose4d".Siemens will inform the affected customers of the described issue via a customer communication that will also explain that the issue will be solved in a future software update.Customer address: (b)(6).

Event Description

Siemens was notified on (b)(4) 2017 that in the middle of the head scan of (b)(6) years old male patient, the radiation dose had risen to the maximum by the end of the scan.It is reported that the patient had received an additional radiation dose after the operator recognized that the patient's height was not properly calculated and the top portion of the patient's head above the eyes was not included in the first toposcan.The dose received is estimated to be the equivalent of one or two additional ct scans of the head.While there is no report of deterministic radiation effects observed, the stochastic effect is an increased cancer risk, which is higher in children than in adults.This reported event occurred in (b)(6).

• Brand Name: SOMATOM FORCE
• 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: 6955424
• MDR Text Key: 90583605
• Report Number: 3004977335-2017-97047
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017,09/20/2017

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: Health Professional
• Device Model Number: 10742326
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2017
• Distributor Facility Aware Date: 09/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 8 YR