SYSMEX TS-10 BN168792

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-02 for SYSMEX TS-10 BN168792 manufactured by Sysmex Ra Co. Ltd..

Event Text Entries

[173442362] The ts-10 instructions for use warn the user in chapter 2 - safety information, section 2. 1 - general information: "in the unlikely event that the system emits an unusual odor or smoke, immediately turn off the main switch and unplug the power cable. Then contact your sysmex service representative. Continued use of the system in such conditions could result in fire, electrical shock or personal injury. " it is unknown if the ts-10 was turned off and/or unplugged. Fuses are located in fuse holders at the back of the system behind a metal plate, not readily accessible to the user. Furthermore, the fuse holders are made of flame resistant material, reducing potential for combustion. Investigation by sysmex corporation (b)(6) (s-corp) is in process.
Patient Sequence No: 1, Text Type: N, H10


[173442363] During normal operation, a user in (b)(6) noted an odor emanating from the tube sorter. A service engineer was dispatched and found one fuse holder to be burned. Replacement of the affected fuse holder resolved the issue for the user. There was no report of harm to the operator or negative impact to patient management.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000515253-2020-00002
MDR Report Key9542013
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-02
Date of Report2020-03-04
Date of Event2019-03-18
Date Mfgr Received2020-02-27
Device Manufacturer Date2017-05-01
Date Added to Maude2020-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. NANCY GOULD
Manufacturer Street577 APTAKISIC RD
Manufacturer CityLINCOLNSHIRE IL 60069
Manufacturer CountryUS
Manufacturer Postal60069
Manufacturer Phone2245439678
Manufacturer G1SYSMEX RA CO. LTD.
Manufacturer Street1850-3 HIROOKANOMURA
Manufacturer CitySHIOJIRI, 399-0702
Manufacturer CountryJA
Manufacturer Postal Code399-0702
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYSMEX TS-10
Generic NameAUTOMATED TUBE SORTER
Product CodeLXG
Date Received2020-01-02
Model NumberTS-10
Catalog NumberBN168792
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYSMEX RA CO. LTD.
Manufacturer Address1850-3 HIROOKANOMURA SHIOJIRI, 399-0702 JA 399-0702


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-02

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