SYNGO WORKFLOW SLR 10558586 NA

MAUDE Adverse Event Report

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.

Event Text Entries

[22458877] The issue was investigated by siemens experts and the root cause for the reported issue was identified as follow. 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


[22458878] 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


MAUDE Entry Details

Report Number2240869-2015-15626
MDR Report Key4932643
Date Received2015-07-17
Date of Report2015-06-29
Date of Event2015-06-26
Date Mfgr Received2015-06-29
Date Added to Maude2015-07-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANASTASIA MASON
Manufacturer Street51 VALLEY STREAM PKWY. MS D-02
Manufacturer CityMALVERN PA 193551406
Manufacturer CountryUS
Manufacturer Postal193551406
Manufacturer Phone6102194834
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSYNGO WORKFLOW SLR
Generic NameSYSTEM, DIGITAL-IMAGE COMMUNICATIONS
Product CodeLMD
Date Received2015-07-17
Model Number10558586
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS GMBH
Manufacturer AddressHENKESSTRASSE 124 ERLANGEN 91052 GM 91052


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-07-17

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