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 2020-01-22 for SOMATOM DEFINITION AS 8098027 manufactured by Siemens Healthcare Gmbh.
[175847023]
Initial reporter's telephone number is: (b)(6). Siemens has completed a technical investigation of the reported event. The analysis of the siemens ct logfiles do not show a malfunction of siemens-manufactured portion of the system. The siemens ct system performed as specified. The log file review also revealed that the non-siemens injector did not generate an error, hence the reason why there was no error message in the ct logfile. Further siemens investigation is not warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
[175847024]
It was reported to siemens that a patient passed away during a ct contrast study on (b)(6) 2020 at approximately 5:37am. According to the initial investigation, the pistol for the contrast medium supply of the injector (a non-siemens device) jammed and due to this issue, air was added to the contrast medium. The patient subsequently died due to an air embolism. Since the siemens ct system has an interface to the injector device, this event is being reported by siemens. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2020-13847 |
| MDR Report Key | 9615750 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-02 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-22 |
| 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 AS |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-01-22 |
| Model Number | 8098027 |
| 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. Death | 2020-01-22 |