MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the analyzer and replaced the vacuum pump, sample loop, and reseated the valves to resolve the issue.The instrument was operating as expected.There was no further action required by the fse.

Event Description

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

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.The vacuum pump was returned to the instrument service center (isc).The investigation by isc confirmed the event.The most probable cause of the reported event was due to a bad motor in the vacuum pump.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 8543665
• MDR Text Key: 142933162
• Report Number: 8031673-2019-00098
• 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,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1