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

Model Number 10742326

Device Problem Loss of Power (1475)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Patient's age was reported as (b)(6).(b)(6).(b)(4).Siemens completed a technical investigation of the reported event.The root cause of the issue was due to the partial facility power outage.There was no device malfunction or report of injury to the patient.No further action is warranted at this time.

Event Description

It was reported to siemens that an infant male had to be rescanned due to a gantry reset after the performance of the topogram (low dose overview scanning procedure) using the reported somatom force system.The patient was sedated and had received a ss-blocker medication to lower the heart rate.There was no reported negative impact due to the necessary additional sedation and additional ss-blocker medication given to the patient in order to perform the rescanning procedure.Although requested by siemens, additional information pertaining to the patient's health status was not provided.A partial facility power outage caused the issue resulting in the need for the gantry to be reset.There was no device malfunction.This report is being conservatively reported with an abundance of caution.

• 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 ; 4486484
• MDR Report Key: 9867046
• MDR Text Key: 190756926
• Report Number: 3004977335-2020-21936
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 2 MO
• Patient Weight: 3