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

Model Number SYNGO LAB DATA MANAGER

Device Problem Smoking (1585)

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

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) and siemens headquarter support center (hsc) reviewed the data provided by the customer.Siemens found that the product performance is meeting specifications and confirmed that the customer is a non-contract customer.The customer stated they will replace the uninterruptible power supply (ups) unit.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Customer reported smoke coming from their syngo instrument.The customer unplugged the unit from the uninterruptable power supply (ups).Customer confirmed there were no delays or impact to patient testing.There are no known reports of patient intervention or adverse health consequences due to the event.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark,, de
• Manufacturer Contact: eric so ; 511 benedict ave; tarrytown, ny ; 5243067
• MDR Report Key: 10101705
• MDR Text Key: 192715330
• Report Number: 2517506-2020-00162
• Device Sequence Number: 1
• Product Code: JQP
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2020

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: 10624077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 05/29/2020
• 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