MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-17 for SYNGO WORKFLOW SLR 10558586 NA manufactured by Siemens Gmbh.
[22458677]
The issue was investigated by siemens experts and the root cause for the reported issue was identified as follows. When a new order arrives and the his-ris (hospital information system) interface job inserts a row into the "visit_order" table. Before additional rows can be inserted by his-ris into the "visit_activity" and "visit_activity_info" tables, the cursor that deletes rows from "visit_order" table without "corresponding visit_activity/visit_activity_info" runs and deletes just-inserted rows in the "visit_order" table. The reported issue only may occur on syngo workflow slr systems running on the vb10c and vb20a software version. In may 2015 siemens informed all potentially affected users about the reported issue via a customer safety advisory notice (csan). The csan was distributed via an update instruction sy037/15/s and reported to fda under c&r report # 2240869-05/08/15-0013-c (z-1704-2015). Siemens is developing a field modification to resolve this matter.
Patient Sequence No: 1, Text Type: N, H10
[22458678]
Siemens became aware of an event when the "visit_order row" for the order was found to be missing even though the "hisrisi_put_ord" stored procedure was performed. Meaning no order would be scheduled as desired for this transaction and will get lost without any indication to the user. This may potentially lead to delay of diagnosis and required treatment. However the probability of such occurrence leading to harm is extremely low. In the worst case scenario a higher probability of potential harm exists for emergency departments with an electronic order workflow and patients with potential brain bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2240869-2015-15269 |
| MDR Report Key | 4932655 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-06-22 |
| Date Mfgr Received | 2015-06-24 |
| Date Added to Maude | 2015-07-22 |
| 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 | ANASTASIA MASON |
| Manufacturer Street | 51 VALLEY STREAM PKWY. MS D-02 |
| Manufacturer City | MALVERN PA 193551406 |
| Manufacturer Country | US |
| Manufacturer Postal | 193551406 |
| Manufacturer Phone | 6102194834 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYNGO WORKFLOW SLR |
| Generic Name | SYSTEM, DIGITAL-IMAGE, COMMUNICATIONS |
| Product Code | LMD |
| Date Received | 2015-07-17 |
| Model Number | 10558586 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS GMBH |
| Manufacturer Address | HENKESSTRASSE 124 ERLANGEN 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-17 |