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 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.The product syngo.Plaza did not contribute to the data loss, as the issue is related to a hardware failure and the syngo.Plaza is a software solution only.No consequences have been reported, neither from this customer nor from the installed base.With this information, a death or serious injury is highly improbable.(b)(6).

Event Description

Due to an identified hard drive failure on the syngo.Plaza server, all studies available in short term storage (sts) were lost.As there is no archive solution in this site, is not possible to restore the data in the sts.Activities are ongoing to evaluate the exact amount of affected studies and the possibility to recover the deleted data; however, the affected data is considered as clinically relevant.The reported event occurred in (b)(6).

• Brand Name: SYNGO.PLAZA
• 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: 8560707
• MDR Text Key: 161434956
• Report Number: 3002808157-2018-12111
• 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: 01/08/2018

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: 01/08/2018
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other