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

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.

• 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 Key: 6665583
• MDR Text Key: 78458411
• Report Number: 1000515253-2017-00022
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• 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 Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse