MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-05 for SOMATOM DEFINITION FLASH 10430603 manufactured by Siemens Healthcare Gmbh.
[178355126]
(b)(6). (b)(4). Siemens has completed a technical investigation of the reported event. Siemens reviewed the device log files and no device malfunction was identified. The root cause is attributed to a workflow issue due to the injector not being manually paired with the ct scanner when the procedure was manually continued. An application specialist informed the customer (user) about the correct workflow for this procedure and the issue was resolved. The ct system performs as specified. No further action is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
[178355127]
It was reported to siemens that a ct topogram (low dose overview scan) with contrast performed with the somatom definition flash had to be repeated. The patient is a three (3) year-old male. The user terminated the contrast study (coupled with contrast media injector) after the topogram. When the user tried to continue the procedure manually, the injector (a separate medical device) was not manually paired again. This is when the ct scanner did not start the volume scan as intended. The user opted to repeat the complete procedure. There was no injury to the patient except for the additional x-ray dose. The patient's current health status is reportedly normal. This report is being submitted with an abundance of caution. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2020-15886 |
| MDR Report Key | 9670583 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-17 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | REBECCA TUDOR |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486484 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH |
| Manufacturer Street | SIEMENSTRASSE 1 |
| Manufacturer City | FORCHHEIM, 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOMATOM DEFINITION FLASH |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-02-05 |
| Model Number | 10430603 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | SIEMENSTRASSE 1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-05 |