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

Model Number SYNGO LAB DATA MANAGER APPLICATION SOFTWARE

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Ccc specialist instructed the customer to unplug the cpu computer from the uninterrupted power supply unit.A siemens field service engineer (fse) was dispatched to the customer site.The fse found that the computer's main board was damaged, due to a short.The fse installed a new syngo cpu computer.The cause of smoke emitted from the syngo cpu computer was due a main board short.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported smoke was emitted from syngo lab data manager central processing unit (cpu) computer.The customer's facility department removed the cpu from their laboratory.There were no reports of injury to staff, damage to property, or impact to patient samples.

• Brand Name: SYNGO LAB DATA MANAGER APPLICATION SOFTWARE
• Type of Device: SYNGO LAB DATA MANAGER APPLICATION SOFTWARE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6229207
• MDR Text Key: 64061260
• Report Number: 2517506-2017-00023
• Device Sequence Number: 1
• Product Code: NSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• 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 APPLICATION SOFTWARE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1