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

Model Number 10863173

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The syngo.Plaza works according to specification.The reported incident occurred due to a hardware issue without contribution from the syngo.Plaza.No consequences have been reported from this customer.Internal id # (b)(4).

Event Description

Siemens became aware of an incident on the syngo.Plaza unit.All images in the short term storage (sts) were corrupted after a hard disk (raid) failure occurred.At the user site the syngo.Plaza system is operated in a standalone mode, i.E.Without archiving functionality.Furthermore ,customer has no other archiving solution available.None of the patient data could be recovered due to all database drives and backup drives being corrupted.Total number and time period of lost data are as follows: total number of images lost: 97868.Total number of studies corrupted: 19343.Timeline of the lost data cannot be determined as all corrupted study records have been removed from the database and the data was present only until december 6, 2019.None of the studies including the recent studies (dated between december 1 and 6, 2019) were available in the modality to resend.There was no injury associated with the issue.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; henkesstrasse 127; 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 9495088
• MDR Text Key: 220753882
• Report Number: 3002808157-2019-11696
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10863173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• 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