MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no similar complaints identified during the search period.The most probable cause of the reported event is pending investigation completion.

Event Description

A distributor reported a tosoh g8 instrument at a customer's site had smoke/fire coming from the back of the instrument while in use.This incident occurred on (b)(6) 2019 but was reported to tosoh on (b)(6) 2020.Tosoh was informed that the customer unplugged the instrument and the smoke/fire went out.No users were injured, and there was no permanent property damage beyond the instrument 's rear electrical plug and reagent container in nearest proximity.The distributor went to the customer's site to investigate and discovered severely melted/damaged power cord at instrument attachment.Testing of power outlet did not reveal any out-of-specification electrical fluctuations.No signs of burning within instrument.The instrument has been shipped to tosoh for further investigation.There was no indication of any patient intervention or adverse health consequences due to the reported event.

Manufacturer Narrative

The g8 instrument was returned to the manufacturer, tosoh bioscience, japan for investigation, but the affected power supply cable for the g8 instrument was returned to kawasaki electric wire co.Ltd.Qa department for investigation on behalf of tosoh as they were the manufacturer of the power cable.The external appearance of the returned product was inspected and found the code markings on the power cable indicated that the cable was produced in 2009.The plug had some dirt but no damage, and the connector was heavily damaged.An x-ray transmission check was performed on the cable, and result found the connector body was severely damaged and the blade catcher was burned out.No abnormality (crimping abnormality, broken conductor, etc.) was found to be a cause of ignition at any point.Manufacturer confirmed the reported g8 fire at the customer's site was due to burned out connector of the power cable.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

(b)(6) 2020 was incorrected entered in both mdr 8031673-2020-00127 and 8031673-2020-00127_follow up1.This supplemental is to correct the date of event to (b)(6) 2019.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 10036714
• MDR Text Key: 190267092
• Report Number: 8031673-2020-00127
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1