MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX CS-5100; SYSMEX AUTOMATED BLOOD COAGULATION ANALYZER

Model Number	CS-5100
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Charred (1086)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pcb is made of flame resistant materials and covered with a metal shield, but excessive heat from the malfunction poses a risk of inhalation of smoke and/or harmful vapors from melted materials.The pcb board is not accessible to the user, and is grounded, reducing the potential for harm due to shock.Investigation for root cause is ongoing by sysmex corporation (b)(4).
Event or Problem Description
A user in (b)(6) reported observing smoke coming from the analyzer and immediately turned off the analyzer.No user harm and no negative patient impact was reported due to this event.The service engineer confirmed that the smoke was from charred components seen on the printed circuit board (pcb).The pcb is located under the right side panel in the upper rear corner of the instrument.The analyzer was replaced.
Additional Manufacturer Narrative
Investigation by s-corp revealed that an unapproved peltier unit was installed on the pcb by the service engineer, taking the pcb out of specification.The peltier unit is responsible for heating and cooling electrical components.This unapproved peltier unit caused an increased temperature and overheating of the transistors and capacitors on the pcb, which caused the pcb to burn.A pcb with the correct peltier unit was installed to resolve the issue.

• Brand Name: SYSMEX CS-5100
• Common Device Name: SYSMEX AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• MDR Report Key: 7606056
• Report Number: 1000515253-2018-00008
• Device Sequence Number: 18890418
• Product Code: JPA
• UDI-Device Identifier: 04987562425426
• UDI-Public: (01)04987562425426
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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
• Operator of Device: Medical Technologist
• Device Model Number: CS-5100
• Device Catalogue Number: BY990757
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/24/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1