MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Computer Software Problem (1112)

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

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was able to reproduce reported computer errors while at customer's site.Fse replaced the computers.The two (2) aia-2000 analyzers were repaired and returned to operational status.

Event Description

This report summarizes 2 malfunction events for the aia-2000 analyzer.The review of events indicated that the aia-2000 analyzer experienced inability to enter data, which caused delay in reporting of critical patient results.These reports were received from various sources.There was no indication of patient intervention or adverse health consequences due to the delayed reporting in patient results.None of these events necessitated remedial action to prevent an unreasonable risk of substantial harm to the public health.

Manufacturer Narrative

For one (1) of the two (2) events the all-in-one computer was returned to the instrument service center (isc) for investigation.Functional testing on the returned all-in-one computer passed.The reported event could not be duplicated.The most probable cause of the reported event could not be determined.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

N/a.

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.For two (2) of the two (2) events reported, the all-in-one computer was returned to instrument service center (isc) for investigation.Functional testing on the returned all-in-one computer confirmed the front led screen was damaged, but overall the computer was functional and reported failure of the computer could not duplicate.The most probable cause of the reported event could not be determined.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• MDR Report Key: 8550738
• MDR Text Key: 146656125
• Report Number: 8031673-2019-00103
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AIA-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1