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

Model Number 10863171

Device Problems Use of Device Problem (1670); Loss of Data (2903)

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

Event Date 12/03/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens factory experts evaluated the reported issue within the acceptable risk threshold for the product, however, relevant risk for the site due to data loss of clinical relevant data was identified.No consequences have been reported from this customer.

Event Description

Our factory experts evaluated the reported issue within the acceptable risk threshold for the product, however, relevant risk for the site was identified.The syngo.Plaza has been configured to use a primary (nas1) and backup (nas2) network attached storage (nas) mount point for archiving purposes.Due to an unrecoverable hardware failure on the nas1 a restoration of all data was performed from the nas2.However, the nas2 did not contain all archived data as on nas1.8523 series dated within the timeframe 2011-2016 were not in the archive and no longer available.This is considered a data loss of clinical relevant data.The root cause analysis was able to limit down the issue to a manual intervention on the nas2's filesystem, which is not no longer traceable.The syngo.Plaza did not contribute to the missing data in the nas2 archive.There are no injuries attributed to this event.The reported event occured in the (b)(6).

• Brand Name: SYNGO.PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8510406
• MDR Text Key: 152528489
• Report Number: 3002808157-2018-15374
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093612
• 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: 01/31/2018

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: 10863171
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 04/12/2019
• 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