MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM SENSATION 64 CARDIAC; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8377520

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Code Available (3191)

Event Date 04/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Siemens completed an investigation of the reported event.According to the siemens service specialists the system has been repaired by replacement of the high-voltage cables.A detailed technical investigation of the logfiles confirmed: after the repair no more scan interruptions were found.The ct scanner is end of support since end of 2019.The material consumption in relation to the installed base is monitored by the capa process (values for the last 3 months see below).No further investigation within the complaint process is deemed necessary.Mat# (b)(4) - hv cable set - march 2020: 0%, february 2020: 0%, january 2020: 1,19%.No general design issue has been identified.No further action is warranted at this time.

Event Description

It was reported that a scan of a sedated (b)(6) infant patient was aborted by the ct scanner due to high voltage problems.The infant patient was diagnosed with ultrasound instead and has been discharged from hospital meanwhile.The exact patient health status is unknown, but no injury except of the non-diagnostic x-ray-dose has been reported to siemens.This event has been reported with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM SENSATION 64 CARDIAC
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, ; GM
• 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: 9990233
• MDR Text Key: 190958391
• Report Number: 3004977335-2020-25978
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K142955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8377520
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2020
• 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 Outcome(s): Other
• Patient Age: 6 MO