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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOSOH CORPORATION G8
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TOSOH CORPORATION G8 Back to Search Results
Model Number G8
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The field service engineer (fse) evaluated the g8 analyzer at the customer's site.Fse performed decontamination of the analyzer which resolved the reported issue.The analyzer was operational.No further action was required by fse.
 
Event Description
This report summarizes 1 malfunction event on the g8 analyzer.The review of the event indicated that the g8 analyzer experienced a retention time error flag.This report was received from one source.There was no indication of patient intervention or adverse health consequences due to the delayed reporting in patient results.This event did not necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.
 
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Brand Name
G8
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 CORPORATION
shiba-koen first building
3-8-2 shiba
minato-ku, tokyo 10586 23
JA   1058623
Manufacturer Contact
doria esquivel
shiba-koen first building
3-8-2 shiba
minato-ku, tokyo 10586-23
JA   1058623
MDR Report Key8552990
MDR Text Key147063214
Report Number8031673-2019-00052
Device Sequence Number1
Product Code LCP
Combination Product (y/n)N
PMA/PMN Number
K131580
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberG8
Device Catalogue Number021560
Was Device Available for Evaluation? Yes
Type of Device Usage N
Patient Sequence Number1
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