MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS, INC. SYMBIA S; SYSTEM, TOMOGRAPHY, XRAY

Model Number SYMBIA S

Device Problems Failure to Read Input Signal (1581); Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)

Patient Problem Physical Entrapment (2327)

Event Date 02/02/2017

Event Type  Injury  

Event Description

At approx 3:30 pm on (b)(6) 2017, nuclear medicine was performing a ventilation/perfusion (vq) scan on an inpatient veteran using a siemens symbia scanner.As detector 1 rotated to the right from the anterior position, the veteran's arm was trapped under the detector and was pulled back to the right.The technologist at the control desk activated the emergency stop button three times but the device failed to stop.Another technologist near the pt pressed a pressure sensitive touch pad inside the scanner that is supposed to stop the device; this too failed to stop the device.The technologist attempted stopping the device by breaking the rail beam with hands/arms which also failed to stop the scanner.The technologist pulled on the light rail stopping the device and the veteran was removed.When the technologist let go of the light rail, the device motion returned.The scanner should have stopped when the light rail beam and the detector contacted the veteran's arm.All three safety stops on the device failed.The technologist assessed the veteran for pain or discomfort.The supervisor, chief, radiology and chief, biomed were immediately notified.The device was taken out of service.An epir was created in response to the incident.The chief of radiology and nuclear medicine supervisor visited the pt in his hospital room to provide disclosure, apologize for the event and ensure that the pt did not receive any harm from the scanner.Electronic medical record documentation of the disclosure was completed.Biomed contacted siemens for service at approx 4:15 pm edt.Biomed reported the malfunction of the symbia device to (b)(4) under the medical device incident report.Siemens service engineers were on site at 8:00 am on (b)(6) 2017.As of 11:00 am edt, the medical center is able to complete vq scans on another device.That machine is a different brand from the symbia s scanner.As of 1:00 pm edt, the cause of the malfunction is unk and the device will remain out of service.Siemens is transmitting the technical logs to an investigative team for analysis.The device was put back into service friday, (b)(6) 2017 at approx 5:00 pm edt after siemens thoroughly tested all emergency stop buttons and confirmed they worked as intended.

• Brand Name: SYMBIA S
• Type of Device: SYSTEM, TOMOGRAPHY, XRAY
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS, INC.; malvern PA 19355
• MDR Report Key: 6311673
• MDR Text Key: 66913533
• Report Number: MW5067748
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYMBIA S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR