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

Model Number G8

Device Problems Fire (1245); Device Operational Issue (2914); Temperature Problem (3022)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: no conclusion is yet available; corrective action and preventive action cr2017-0044 has been initiated to fully investigate the reported event.

Event Description

On (b)(6) 2017 a customer reported that the g8 instrument burst into flames while being run on (b)(6) 2017.There was no reported injury as a result of this event.The customer requested a replacement g8 instrument.A field service engineer was dispatched to further investigate the reported event.

Manufacturer Narrative

Tosoh identified that a report submitted on 16-nov-2018 under mfr report #: 8031673-2017-00299 and uf/importer report #: (b)(4) was incorrect and does not exist.The correct numbers are mfr report #: 8031673-2017-00291 and uf/importer report #: (b)(4); these numbers were transposed.This report corrects the error.H.3 device evaluated by manufacturer a tosoh field service engineer (fse) arrived at the customer's site on (b)(6) 2017 and was able to take pictures of the damage to the g8 analyzer and environment in which it was being used.Based on the initial examination of the analyzer on-site by the fse, there was no evidence of the fire inside the analyzer; the origin of the fire was at the plug that goes into the analyzer from the electrical outlet.There was observed fire damage on the outer skins of the device and charring at the plug.It was also observed that there were plants hanging right above the analyzer, which could contribute to fluid ingress and the analyzer was placed within inches of the sink.The g8 analyzer was returned to the manufacturer for further investigation.It was confirmed with returned g8 that around the periphery of the connection part of the power cord and inlet was melted and burned out, but there was no evidence of fire spreading inside the analyzer.The circuit protector was found "on" although it would have turn "off" automatically when an overcurrent flew due to failure of the analyzer.From the investigation, it is concluded that this fire did not result from a malfunction of the analyzer.Since the installation place was next to the sink, it is possible that the electrical leakage occurred due to moisture adhering to the inlet part, and that the fire occurred.It is recommended to avoid installing the analyzer in places where the location has high humidity and there is a possibility of direct water being applied, such as a sink.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(6) from (b)(6) 2016 through aware date 18-dec-2017.There were no similar complaints found during the searched period.The g8 variant analysis mode operator's manual under safety precautions states the following: caution: carefully select the installation location · refer to "chapter 2, section 2.4 installation locations" in this manual and select an appropriate location for installation.2.4 installation locations do not install the unit in the following locations: · locations with large fluctuations in the power source or strong magnetic fields nearby.Locations in the path of direct air currents.Locations with rapid temperature changes.Locations with a large amount of dust or dirt or poor ventilation.· locations with excessive vibrations or unstable locations.Locations with high humidity or a flame nearby.Installation environment: install the unit on an even table top with no direct sunlight, air currents, dust or vibrations.Operate the unit under the conditions indicated below.Environmental conditions: temperature: 15°c ~ 30°c.Humidity: 40% ~ 80% (no condensation).Dust: ~ the quality in an office.Altitude: 6,600 ft.Caution: do not use in an environment with drastic temperature fluctuations.Such an environment can cause condensation to form, resulting in short circuits or improper functioning.The most probable cause of the reported event was electrical leakage due to moisture adhering to the inlet part of the g8 analyzer, causing the fire.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

Event Description

N/a.

Manufacturer Narrative

Please note that this mdr mfr report #: 8031673-2017-00291 / importer report #: 3005529799-2017-00299 was previously submitted to the fda on 16nov2018; it was recreated as mfr report #: 8031673-2017-00291 per request by the fda mdr data systems team representative.H.3 device evaluated by manufacturer: a tosoh field service engineer (fse) arrived at the customer's site on (b)(6) 2017 and was able to take pictures of the damage to the g8 analyzer and environment in which it was being used.Based on the initial examination of the analyzer on-site by the fse, there was no evidence of the fire inside the analyzer; the origin of the fire was at the plug that goes into the analyzer from the electrical outlet.There was observed fire damage on the outer skins of the device and charring at the plug.It was also observed that there were plants hanging right above the analyzer, which could contribute to fluid ingress and the analyzer was placed within inches of the sink.The g8 analyzer was returned to the manufacturer for further investigation.It was confirmed with returned g8 that around the periphery of the connection part of the power cord and inlet was melted and burned out, but there was no evidence of fire spreading inside the analyzer.The circuit protector was found "on" although it would have turn "off" automatically when an overcurrent flew due to failure of the analyzer.From the investigation, it is concluded that this fire did not result from a malfunction of the analyzer.Since the installation place was next to the sink, it is possible that the electrical leakage occurred due to moisture adhering to the inlet part, and that the fire occurred.It is recommended to avoid installing the analyzer in places where the location has high humidity and there is a possibility of direct water being applied, such as a sink.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(6) from 18-nov-2016 through aware date 18-dec-2017.There were no similar complaints found during the searched period.The g8 variant analysis mode operator's manual under safety precautions states the following: caution: carefully select the installation location · refer to "chapter 2, section 2.4 installation locations" in this manual and select an appropriate location for installation.2.4 installation locations do not install the unit in the following locations: · locations with large fluctuations in the power source or strong magnetic fields nearby · locations in the path of direct air currents · locations with rapid temperature changes · locations with a large amount of dust or dirt or poor ventilation · locations with excessive vibrations or unstable locations · locations with high humidity or a flame nearby installation environment install the unit on an even table top with no direct sunlight, air currents, dust or vibrations.Operate the unit under the conditions indicated below.Environmental conditions temperature: 15°c ~ 30°c humidity: 40% ~ 80% (no condensation) dust: ~ the quality in an office altitude: 6,600 ft.Caution: do not use in an environment with drastic temperature fluctuations.Such an environment can cause condensation to form, resulting in short circuits or improper functioning.The most probable cause of the reported event was electrical leakage due to moisture adhering to the inlet part of the g8 analyzer, causing the fire.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.H.11 corrected data: please refer to section: g5.Incorrect numbering mdr#: 8031673-2017-00299 / importer report #: 3005529799-2017-00291 was corrected to mfr report #:8031673-2017-00291.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, 105-8 623; JA 105-8623
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (IMPORTER); 6000 shoreline court; suite 101; south san francisco CA 94080
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7197229
• MDR Text Key: 97467401
• Report Number: 8031673-2017-00291
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2018
• Distributor Facility Aware Date: 10/21/2018
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/16/2018
• Date Manufacturer Received: 10/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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