MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Pressure Problem (3012)

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

Event Date 06/11/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2015 a field service engineer (fse) was dispatched.The fse found that the rts and pressure would not change when the fr was adjusted.The fse replaced the check valves and primed.The rts and pressure will now change when the fr is adjusted.The fse calibrated and ran controls and all within acceptable results.The g7 analyzer was functioning as intended and errors cleared.No further action required by field service.The probable cause of the event was related to the check valves.A complaint history review for serial number (b)(4) was conducted from 11-may-2014 through (b)(4) 2015 for similar complaints.There were two (2) similar complaints identified during the search period.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

On (b)(6) 2015 a customer reported a high flow rate with the g7 analyzer.A field service engineer (fse) was dispatched.The customer is unable to run hbaic patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hbaic patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: G7
• Type of Device: G7
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7343309
• MDR Text Key: 102736423
• Report Number: 8031673-2018-01889
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011434
• 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
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G7
• Device Catalogue Number: 019327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2018
• Distributor Facility Aware Date: 06/11/2015
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/15/2018
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• 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