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

Model Number 10863171

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

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

Event Date 10/07/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.Per the potential complaint report, there was no injury associated with this issue.On 2017-10-26 customer reported missing or corrupted images appearing in syngo.Plaza.During the analysis it was identified that on the (b)(6) 2017, one of the hard drives used by the syngo.Plaza's short term storage had file system problems caused by hardware failures.(b)(6.

Event Description

Permanent loss of 15 studies was discovered in the syngo.Plaza's database.The syngo.Plaza product did not contribute to the data loss as the issue is related to a hardware failure and the syngo.Plaza system is a software only solution.No consequences have been reported from this customer.The lost data is considered clinically relevant as the studies were between 1 and 6 months old and may be still requested for comparison.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: 8556760
• MDR Text Key: 161429911
• Report Number: 3002808157-2017-02749
• 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: 10/26/2017

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: 10/26/2017
• Initial Date FDA Received: 04/26/2019
• 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