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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO LAB DATA MANAGER Back to Search Results
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.
 
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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 Key10101705
MDR Text Key192715330
Report Number2517506-2020-00162
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 NumberSYNGO LAB DATA MANAGER
Device Catalogue Number10624077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/15/2020
Initial Date FDA Received05/29/2020
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 Number1
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