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

Model Number 10742326

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880)

Patient Problem No Code Available (3191)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Siemens completed an investigation of the reported event.The somatom force system is currently running software version va50a.The scan mode used during the procedure has a known issue with high table pitch.This issue has been solved with updated software version vb20.The affected system will be updated to vb20 on january 28, 2020.The corresponding recall has been reported to the national competent authorities including the fda separately as ct035/19/s (fda z-2274-2019).

Event Description

It was reported to siemens that a (b)(6) patient was initially scanned with the somatom force ct system; however, there was an image reconstruction system (irs) error and the image could not be obtained.The technician tried again to rescan but was unsuccessful.The technician the restarted the ct system and was able to complete the examination.There was no report of patient injury; however, the patient received additional x-ray dosage due to the reported issue.Therefore, this report is being submitted with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM FORCE
• 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 19355 ; 6104486484
• MDR Report Key: 9570734
• MDR Text Key: 175005891
• Report Number: 3004977335-2020-11469
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/09/2020
• 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: Reuse
• Removal/Correction Number: Z-2274-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 MO
• Patient Weight: 7