MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Decrease in Pressure (1490)

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

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the g8 analyzer.The fse replaced several valves and left the analyzer operational.The valves were returned to the tosoh instrument service center (isc).Isc could not duplicate the failures in the reported events.

Event Description

This report summarizes 1 malfunction event for the g8 analyzer.The review of the event indicated that the g8 analyzer experienced pressure low error messages, which caused delayed reporting of critical patient results.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.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; ste 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 8543683
• MDR Text Key: 147062388
• Report Number: 3005529799-2019-00080
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1