MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH, CT QT DCU SOMATOM FORCE; SYSTEM, XRAY, TOMORGRAPHY, COMPUTED

Model Number 10742326

Device Problems Failure to Power Up (1476); Device Inoperable (1663)

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

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

Siemens has conducted a thorough investigation of the reported event.It was determined that a communication error occurred within the umas causing the system to restart.As the reported error is very sporadic, the communication error will be resolved in the next service pack release.Additionally, the patient is reported to have suffered no lasting health effects from the procedure and contrast media.This event occurred in (b)(6).

Event Description

It was reported to siemens that a malfunction occurred during a procedure on the somatom force resulting in an adverse event.A three day old patient was sedated and received 5ml of diluted imeron 400 contrast media.During the procedure, the topo started but the spiral did not start and caused a delay in procedure.The patient was transferred to an alternate system where another 5ml of contrast media was administered 26 minutes later.The delay in procedure did not result in any health harm to the patient, however, the patient received twice the amount of contrast media and was exposed to a repeat topo exam.

• Brand Name: SOMATOM FORCE
• Type of Device: SYSTEM, XRAY, TOMORGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH, CT QT DCU; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH, CT QT DCU; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5987115
• MDR Text Key: 55926287
• Report Number: 2240869-2016-05147
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/02/2016

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?: No
• Device Operator: No Information
• Device Model Number: 10742326
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2016
• Initial Date FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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): Other
• Patient Age: 3 DA
• Patient Weight: 3