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 2020-01-09 for SOMATOM FORCE 10742326 manufactured by Siemens Healthcare Gmbh.
[175005891]
(b)(6). (b)(4). Siemens completed an investigation of the reported event. The somatom force system is currently running software version va50a. The scan mode used during the procedure has a known issue with high table pitch. This issue has been solved with updated software version vb20. The affected system will be updated to vb20 on january 28, 2020. The corresponding recall has been reported to the national competent authorities including the fda separately as ct035/19/s (fda z-2274-2019).
Patient Sequence No: 1, Text Type: N, H10
[175005892]
It was reported to siemens that a (b)(6) patient was initially scanned with the somatom force ct system; however, there was an image reconstruction system (irs) error and the image could not be obtained. The technician tried again to rescan but was unsuccessful. The technician the restarted the ct system and was able to complete the examination. There was no report of patient injury; however, the patient received additional x-ray dosage due to the reported issue. Therefore, 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 | 3004977335-2020-11469 |
| MDR Report Key | 9570734 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2020-01-09 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2274-2019 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOMATOM FORCE |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-01-09 |
| Model Number | 10742326 |
| 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 | 2020-01-09 |