MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO DYNAMICS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 10091805

Device Problems Use of Device Problem (1670); Data Problem (3196); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.Siemens service and installation personnel are working with the site personnel to manually correct demographic data of the 350 patient studies.The effort is ongoing and the site is crosschecking the displayed patient demographic study information with other sources during the manual corrections.There are no reported instances of harm occurring from this issue.Per the potential complaint report, there was no injury associated with this issue.No data mix-up or loss occurred which would result in the need for a patient rescan.The syngo dynamics (or the mla) products have not caused or contributed to the crossed data.No reasonably foreseeable path to occurrence of harm can be determined.

Event Description

The issue occurred during a siemens-healthcare installation upgrade of the site's (b)(6) a (mla) system from sw version va20 to va30.An error occurred during the installation in the configuration between the mla and syngo dynamics (sd) products.It resulted in a crossed patient data situation for 350 patients.The patient demographic data displayed for the studies in the syngo dynamics product was affected but there was no change in the imaging modalities study patient demographics data.The error was identified and the configuration was corrected.There is no reasonably foreseeable clinical impact to the crossed data as the site is aware to cross-check the patient demographic information with other available sources while the manual corrections are taking place.The imaging modality study and patient demographic data is not affected.There are no injuries attributed to this event.

• Brand Name: SYNGO DYNAMICS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8560711
• MDR Text Key: 161429441
• Report Number: 3002808157-2018-23735
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10091805
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other