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

Model Number 8377520

Device Problem Human Factors Issue (2948)

Patient Problems Nausea (1970); Chemical Exposure (2570)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

Siemens conducted a comprehensive evaluation of the reported events.It is thought that most likely the hole in the plexi ring, caused by the first patient, enabled dust from the carbon brushes that were inside the gantry to come out by the rotating wind.The dust of used carbon brushes is rated as non-toxic, and under normal conditions does not escape from the gantry during regular operation.Siemens concludes that this is the only explanation whereby the patient could have smelled a metallic odor.Consequently, this event is determined to be user error, as the system should not have been used at that time because the gantry was unsafe for operation due to the damaged plexi ring.No system malfunction product issue was detected.After replacement of the damaged plexi ring the system was fully operational.

Event Description

It was reported to siemens on (b)(6) 2018, that two situations in a row had occurred while the somatom sensation was performing scans on two different patients on the same day.The first patient was placed on the table and damaged the plexi-ring with his knee.This patient was not injured, and after he was repositioned the scan was completed, irregardless of the fact that the plexi-ring was damaged.The second patient was placed in the same ct device, and she complained about a metallic smell coming from the gantry while her ct scan was taking place.Immediately following the scan, the second patient complained of nausea, upset stomach, and headache; and sought treatment at the local emergency room 5 hours later that day for her symptoms.The patient was later discharged from the emergency room with the diagnosis of, " chemical inhalation".Upon discharge the patient was feeling better and had no further issues.This event occurred in the united states.

• Brand Name: SOMATOM SENSATION
• 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: 7626788
• MDR Text Key: 111976929
• Report Number: 3004977335-2018-33050
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8377520
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2018
• Distributor Facility Aware Date: 05/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2018
• Date Manufacturer Received: 05/30/2018
• 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 Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 103