MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX CS-2100I; AUTOMATED COAGULATION ANALYZER

Model Number	CS-2100I
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sysmex cs-2000i/2100i instructions for use (ifu), chapter 2 - safety information, section 2.2 - general information warns the user: should the instrument emit any unusual odors or smoke, turn the main switch off immediately and unplug the power cable.Contact your local technical representative.The user appropriately turned off the analyzer, disconnected the power, and contacted siemens healthcare diagnostics.The se replaced the motor block no.126 assy.Without resolution.The se returned to the customer site and replaced pcb no.1279, which resolved the issue.The analyzer cover and motor encoder disc are made of flame resistant materials, but excessive heat from a malfunction poses a risk of inhalation of smoke and/or harmful vapors from scorched materials.The affected parts are covered with a metal sheet and not accessible to the user, reducing potential harm.Sysmex corporation japan (s-corp) requested the parts for investigation.
Event or Problem Description
A user in (b)(6) reported a burnt odor emanating from the analyzer.The user immediately turned off the analyzer, disconnected the power, and contacted siemens healthcare diagnostics.A siemens service engineer (se) was dispatched the same day and found the cp unit drive of motor block assembly no.126 was burnt, parts of the motor encoder disc were melted, a fuse on the power supply (wiring cord no.5391) was blown, and printed circuit board (pcb) no.1279 was damaged.Smoke was observed; however, no open fire was observed.No users sought medical attention due to the burning odor.No user or patient harm occurred.
Additional Manufacturer Narrative
Sysmex corporation (b)(4) (s-corp) completed the investigation.S-corp determined a short circuit from either the printed circuit board (pcb) no.1279 or the stepping motor (a component of motor block assembly no.126) caused the event.These parts are connected; therefore, s-corp was unable to determine the origin of the short circuit.S-corp determined this is 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 CS-2100I
• Common Device Name: AUTOMATED 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: 8478205
• Report Number: 1000515253-2019-00009
• Device Sequence Number: 942035
• Product Code: JPA
• UDI-Device Identifier: 04987562409471
• UDI-Public: (01)04987562409471
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: Health Professional
• Device Model Number: CS-2100I
• Device Catalogue Number: 06372511
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 08/18/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1