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

Model Number 10014063

Device Problems Use of Device Problem (1670); Loss of Data (2903); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/19.Activities to repair the defective database at the user site as well as review for potentially missing data and its further restoration are on-going.The final amount of data loss (if any) can be determined only after the recovery activities at site are completed.No consequences from the user have been reported so far.Customer's address: (b)(6).

Event Description

Siemens became aware of an issue with two oracle database partitions on the syngo imaging system.The oracle database partition is a table that contains dicom instance details for the syngo imaging archive.These partitions are not accessible due to i/o errors in the filesystem.Images maintained in these parts of the database cannot be opened.No impact on clinical routine at the site has been observed.The user continues to read and save current examinations.However, if prior images are needed for a follow up reading and they are located in the inoperable parts of the database, it would not be possible to access them leading to a reduced basis for clinical diagnosis.The root cause of the reported issue is a hardware error.The syngo imaging product did not contribute to the unavailability of images.There are no injuries attributed to this event.The reported event occurred in (b)(6).

• Brand Name: SYNGO IMAGING
• 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: 8541559
• MDR Text Key: 160622002
• Report Number: 3002808157-2019-69738
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10014063
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2019
• 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