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

Model Number XN-10

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2017

Event Type  malfunction  

Manufacturer Narrative

The pcb is being sent to the manufacturer for further investigation to determine the root cause of the event.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 burning odor coming from the back of the analyzer, and powered off the analyzer.A sysmex field service engineer (fse) arrived on site, and found the wiring cord and printed circuit board (pcb) were burnt.

Manufacturer Narrative

Sysmex corporation (b)(4) (s-corp) completed the investigation of the printed circuit board (pcb) and wiring cord.S-corp discovered two pins on pcb no.30001 were broken causing a short circuit.It is likely the pcb and wiring cord burned as a result of the short circuit.It is unknown how the pins became broken.This issue was determined to be an isolated event.There was no systemic deficiency identified, as no similar issue was reported.No further corrective action will be taken.

• 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: 7155248
• MDR Text Key: 96123614
• Report Number: 1000515253-2017-00043
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: 04987562424214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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