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

Model Number	10590000
Medical Device Problem Codes	Break (1069); Unintended Power Up (1162); Premature Activation (1484)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Siemens initiated an investigated the reported event.The preliminary investigation revealed the metal plug connected to the foot switch was broken with exposed wiring.This condition could result in a short circuit.A hardware investigation of the foot switch with the broken connector will be performed by siemens experts.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to siemens that during a patient interventional procedure using the somatom definition edge system, a single sequence scan was released without user initiation.This event was caused by a foot switch (foot pedal) with a broken connector.In total, five people were unintentionally exposed to the additional x-ray dose (single sequence scan with a duration of 0.5 seconds).The five people included: the patient who was on the treatment table; a physician who was positioned adjacent to the opposite side of the system gantry; one technician who was near the physician; one technician who was kneeling in front of the gantry and; a nurse anesthetist who was positioned at the foot end of the treatment table.The incident occurred at the beginning of the interventional procedure.The physician wanted to release the scan with the foot switch, but it was not connected.Therefore, one of the technicians went into the room in order to connect the foot switch.As soon as the technician connected the foot switch to the scanner, a single scan was released.There was no reported injury to any of the five people, except for the additional single sequence scan x-ray dose.Additional information is pending completion of the investigation.
Additional Manufacturer Narrative
As previously reported, the preliminary investigation performed by siemens revealed that the metal plug connected to the foot switch was broken with exposed wiring.This condition could result in a short circuit.Siemens completed the technical investigation.The investigation revealed there was no general design issue.It was clearly visible that the foot switch was damaged (housing, cable and plug were visibly damaged).The user connected the damaged foot switch with an already loaded fluoro protocol.The ct system immediately started the fluoroscopy and indicated x-ray emission.During the reboot, this defective footswitch (short circuit) would have been recognized by the system.A spiral ct scan cannot be triggered by the foot switch.Siemens did not identify a design issue related to this event.No remedial action is deemed necessary.

• Brand Name: SOMATOM DEFINITION EDGE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10395793
• Report Number: 3004977335-2020-40486
• Device Sequence Number: 3564099
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10590000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other