MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for SAGINOVA manufactured by Eckert & Ziegler Bebig Gmbh.
[49256976]
The software problem had been observed in two clinics in (b)(6) and had been reported to us as complaints. In both cases the patient data had been saved before system shutdown so that the patient data were available. To avoid cases where the software problem might reoccur and the patient data are not saved, an urgent field safety notice was sent to all users of saginova devices on 18 march 2016. Competent authorities have been informed about this field safety corrective action including fda (mdrpolicy@fda. Hhs. Gov) on 22 march 2016. We took immediate action to install the electronic reporting at eckert & ziegler bebig. However the installation created considerable technical problems which took our it department considerable time to solve. Therefore the electronic reporting of this field safety correction has been delayed until now. We also had several questions on how to duly fill out this template if it is not an incident that is reported but a field safety corrective action. As we have not received a reply until now this template has been filled out to the best of our knowledge. Our competent authority in (b)(6) has closed the file on 19 april 2016. Software problem reproduced at bebig.
Patient Sequence No: 1, Text Type: N, H10
[49256977]
Cases of lost patient treatment data have been reported to bebig. During system shutdown of the saginovacontrol software, valid data might be rejected and lost due to an error in the exception handling procedure by the software. The error can potentially affect every saginovasystem. Data that is already stored on the system and shown after system startup is not affected and remains available. Loss of the information about performed maintenance, quality assurance check or treatment fraction may cause inconsistency in the documentation and confusion of the user. This could result in the delivery of the wrong treatment session or repeated treatment of already delivered fractions and possibly cause adverse health consequences. The resolution of the issue will be available with the next saginovasoftware release scheduled for early july. Valid data is available as long as the system is not shut down and must be printed or saved as pdf files immediately after execution of the treatment procedure or maintenance check. Furthermore the user must check that the treatment fraction number during fraction import is consistent with the treatment plan and previous treatment reports. All saginova users must be informed that they have to comply with the preventative user actions as described in detail in the following section until the problem has been resolved with the new software release. Recommended user action i: print all quality assurance, maintenance and treatment reports directly after they have been generated or save all respective pdf-files on a secure file system, which is approved to store patient data. Recommended user action ii: double check the treatment fraction number during fraction import on the saginovacontrol console with the respective treatment plan from sagiplanand all existing treatment reports from saginova in case if the fraction numbers of newly imported fractions don't overlap with existing treatment reports, the treatment can be performed followed by recommended user action i. In case the fraction numbers of newly imported fractions do overlap with existing treatment reports, the import should be rejected and the following steps should be followed re-import the fraction(s) missing in the system. Import the fraction(s) that need to be treated next. Delete the fractions generated, as they are shown with a wrong status. Treat the fraction(s) as scheduled and follow by recommended user action i.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000310011-2016-00001 |
| MDR Report Key | 5758155 |
| Date Received | 2016-06-29 |
| Date of Report | 2016-06-28 |
| Date of Event | 2016-03-04 |
| Date Mfgr Received | 2016-03-04 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2016-06-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR SVEN LANGER |
| Manufacturer Street | ROBERT R |
| Manufacturer City | BERLIN, 13125 |
| Manufacturer Country | GM |
| Manufacturer Postal | 13125 |
| Manufacturer Phone | 0941084734 |
| Manufacturer G1 | ECKERT & ZIEGLER BEBIG GMBH |
| Manufacturer Street | ROBERT R |
| Manufacturer City | BERLIN, 13125 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 13125 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAGINOVA |
| Generic Name | HDR BRACHYTHERAPY AFTERLOADER |
| Product Code | JAQ |
| Date Received | 2016-06-29 |
| Model Number | SAGINOVA |
| Catalog Number | SAGINOVA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECKERT & ZIEGLER BEBIG GMBH |
| Manufacturer Address | ROBERT R?SSLE STR. 10 BERLIN, 13125 GM 13125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-29 |