MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO LAB DATA MANAGER

Model Number SYNGO LAB DATA MANAGER

Device Problem Mechanical Problem (1384)

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

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse determined that the syngo server contributed to the smoke observed by the customer and ordered new syngo lab data manager (sldm) device.In subsequent visits, the cse performed the following: replaced ups(uninterruptible power supply) unit, monitor, keyboard, mouse and the syngo ldm standard capacity server, installed the sldm software, document guide and patch management, configured the settings on the sldm, establish internet and lis (logistics information systems) connection, imported rule package for sldm, and confirmed that all tests calculations were crossing over into lis.Siemens further investigated the issue and determined that dust accumulation on the device contributed to the smoke from sldm device.The device is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that smoke emitted from a syngo lab data manager (sldm) device.A fire extinguisher was used to put out the smoke.The device was removed from the lab.The customer indicated that the technicians evacuated the room and did not require medical attention.The customer alleged that there was a delay in testing patient samples for 2 hours and samples were sent to an alternate laboratory for testing.The customer alleged that there was an impact in determining the treatments for oncology patients and alleged that there was an impact to computed tomography (ct) patients, who were waiting for the ct scans.The customer did not specify how these patients were impacted but indicated that there was no harm to user or patient due to this issue.There are no known reports of adverse health consequences due to the event.Statements attributed to the customer are derived from information submitted to the siemens complaint handling system and haven't been verified.

Manufacturer Narrative

Siemens filed initial mdr 2517506-2019-00298 on 25-jul-2019.Additional information (26-jul-2019): siemens received additional information from the customer regarding how the delay in reporting results impacted computed tomography (ct) patients.The customer indicated the patients' kidney function needed to be tested prior to the ct scan and testing for blood urea nitrogen (bun) and creatinine were required.The samples were sent out for testing due to the syngo lab data manager (sldm) malfunction.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: SYNGO LAB DATA MANAGER
• Type of Device: SYNGO LAB DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8828694
• MDR Text Key: 175413470
• Report Number: 2517506-2019-00298
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYNGO LAB DATA MANAGER
• Device Catalogue Number: 10638933
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 07/26/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1