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 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

Field service was not dispatched as the customer declined due to deciding to upgrade to a g8.The most probable cause of the reported event could not be determined.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).

Event Description

On (b)(6) 2016, a customer reported pressures over limit and grad sensor errors with their g7 analyzer.The customer initially noted issues with quality control (qc) coming in low and with poo peaks.Technical support sent the customer a new lot of qc and advised the customer to adjust the flow rate but there was no change to retention times.The customer called back and reported grad sensor error and pressure overlimit.Technical support then advised the customer to change the filter and reboot but the pressure overlimit error persisted.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: 7344895
• MDR Text Key: 103157363
• Report Number: 8031673-2018-01892
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• 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: 03/16/2018
• Distributor Facility Aware Date: 07/06/2016
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/16/2018
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2012
• 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