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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

The (b)(6) is working as designed and according to the specifications; the reported data loss was unrelated to the (b)(6) product.The (b)(6) product did not contribute to the partial data loss at the concerned site.No consequences have been reported from this user.(b)(6).

Event Description

Siemens became aware of data loss on the (b)(6) system.Hdds at the clinical facility were damaged or became unavailable due to power loss.This scenario corrupted user's entire raid storage volume (hosting system and data).After system recovery was performed and data was restored from all available sources, the total extent of data loss was determined as follows: (b)(4) studies, (b)(4) series, (b)(4) images.These (b)(4) studies are dated within the time period of (b)(6) 2002 to (b)(6) 2019.They are assessed as partially clinical relevant.The (b)(6) is working as designed and intended, and the reported data loss was unrelated to the (b)(6) product.There are no injuries attributed to this event.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 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: 8541438
• MDR Text Key: 160890902
• Report Number: 3002808157-2019-69334
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132532
• 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: 02/13/2019

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: 10863171
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2019
• 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