MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO IMAGING XS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 10496279

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019 there are no injuries attributed to the reported event.However, the investigation whether clinically relevant data loss occurred is on-going.The amount of data loss is currently unknown.Activities are ongoing at site to evaluate the amount of data lost and after those activities are finished the amount of data lost will be known.This activity will take several weeks.(b)(6).

Event Description

Since 2010, the image archive is done in one nas (network attached storage), which is attached to the syngo imaging xs server.On 15th of december, the nas system crashed suddenly and after a restarted, one of the logical drives disappeared from the operating system.The drive has been re-enabled and during the investigations it was identified that several zip files containing the patient studies are corrupted.The reported event occurred in (b)(6).

Manufacturer Narrative

The logical drive was re-enabled and during the investigations it was identified that 155 zip files containing patient studies were corrupted.During the final check it was determined that these 155 series were lost and the data is unrecoverable.The product syngo imaging xs did not contribute to the data loss as the issue is related to a hardware failure and the syngo imaging xs is a software solution only.No consequences have been reported from this customer.

• Brand Name: SYNGO IMAGING XS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 8544684
• MDR Text Key: 161428896
• Report Number: 3002808157-2017-65147
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K082430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10496279
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other