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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX XN-10; AUTOMATED HEMATOLOGY ANALYZER

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SYSMEX CORPORATION, I SQUARE SYSMEX XN-10; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
Model Number XN-10
Event Date 02/02/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation by sysmex corporation in (b)(6) determined lightning caused an excessive voltage that exceeded the product standard to be applied to the power supply unit.The surge absorber of the board was damaged.There was no abnormality found in the manufacturing of the product.The board was replaced and the instrument was operational.Any incident with excessive heat has the potential to cause user harm.The pcb is made of flame resistant materials and covered with a metal shield, but excessive heat from the event poses a risk of inhalation of smoke and/or harmful vapors from melted materials.The pcb is not accessible to the user, and is grounded, reducing the potential for harm due to shock.
 
Event Description
The user reported a power outage occurred during a thunderstorm.The analyzer power remained on through the use of an uninterrupted power supply (ups).When the user tried to perform sample analysis, the analyzer was not functioning.A sysmex field service engineer (fse) went on site and found the surge absorber on the printed circuit board (pcb) power supply was charred due to excessive heat.
 
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Brand Name
SYSMEX XN-10
Type of Device
AUTOMATED HEMATOLOGY ANALYZER
Manufacturer (Section D)
SYSMEX CORPORATION, I SQUARE
262-11 mizuashi
noguchi-cho
kakogawa-city, hyogo 675-0 019
JA  675-0019
Manufacturer (Section G)
SYSMEX CORPORATION, I SQUARE
262-11 mizuashi
noguchi-cho
kakogawa-city, hyogo 675-0 019
JA   675-0019
Manufacturer Contact
peter shearstone
577 aptakisic rd
lincolnshire, IL 60069
2245439514
MDR Report Key6665583
MDR Text Key78458411
Report Number1000515253-2017-00022
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K112605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/23/2017
1 Device 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 NumberXN-10
Device Catalogue NumberAP795756
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/02/2017
Initial Date FDA Received06/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
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