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

Model Number 11061630

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's telephone number is: (b)(6).(b)(4).Siemens could not complete a detailed technical investigation of the reported event due to missing logfiles.Based on the information provided, is speculated by the manufacture that a device malfunction had not occurred; however, a root cause cannot be definitively determined.Further action is not warranted at this time.

Event Description

It was reported to siemens that during a follow-up application training the siemens application specialist was made aware of an event at the facility that occurred at the facility.It was reported that an (b)(6) infant had to be re-scanned on the somatom go.All system.The system had been delivered to the facility during may 2020.Unfortunately, the issue was not reproducible.The customer was also unable to clarify which workflow they used, as it was a stressful situation with many physicians and other persons involved.The customer stated the system was not able to scan after the first topogram (low dose overview scan).Therefore, the lead shielding was removed, and the infant patient received another topogram (typical x-ray dose of less than 1msv).Beside the low-level additional x-ray dose, no other injury to the infant patient was reported to siemens.The user was trained how to use the system with patients wearing radiation protection shielding.This report has been filed with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM GO.ALL
• 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: 10316359
• MDR Text Key: 205172707
• Report Number: 3004977335-2020-37758
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869151588
• UDI-Public: 04056869151588
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K200524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• 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 Age: 11 MO