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

Model Number 1074236

Device Problems Image Display Error/Artifact (1304); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Siemens determined that the root cause of this device malfunction is user error.Due to the operator of the somatom force not implementing the addendum during the ct scan of the patient, the device malfunctioned.No further investigation is being conducted at this time.

Event Description

It was reported to siemens on (b)(6) 2018 that a malfunction occurred while operating the somatom force system.The customer had been made aware of the voluntary correction and removal action which was initiated and notified to the fda on (b)(6) 2017, with report id # 2240869-04/05/17-0012-c.The addendum to the instructions for use of the somatom force system, with software version va50a is related to the use of the turbo flash mode with very short scan ranges.The addendum informs the customer that when selecting the turbo flash mode in combination with a spiral scan length of less than or equal to 27 mm, the image reconstruction will possibly fail for this scan.The workaround suggested in the addendum is to always select a spiral scan length of more than 27 mm or to switch to another mode instead.The operator in this incident selected a 27 mm range, and the reconstruction of the ct pictures failed, causing the system malfunction.The operator confirmed that he was aware of this addendum, but unfortunately during the procedure with a (b)(6) infant male patient, the operator mixed up the minimum scan range, and the newborn patient got a repeat examination with an additional x-ray dose.According to available information, there was no further negative impact to the newborn patient.This event occurred in the united states.

• Brand Name: SOMATOM FORCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS; computed tomography; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS; computed tomography; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: mary stamer ; 40 liberty boulevard; ms-65-1a; malvern, PA 19355-9998 ; 6104486485
• MDR Report Key: 7621160
• MDR Text Key: 112307757
• Report Number: 3004977335-2018-31169
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1074236
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2018
• Date Manufacturer Received: 05/24/2018
• 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 Age: 3 DA