MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Technical support shipped a replacement cable to the site for the customer to replace and resolve the issue.The analyzer was operational.No further action was required by technical support.

Event Description

This report summarizes 1 malfunction event on the aia-360 analyzer.The review of the event indicated that the aia-360 analyzer had a broken level sense wire, which caused delayed reporting of critical patient test 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.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 105-8 623; JA 105-8623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 8553040
• MDR Text Key: 146090142
• Report Number: 8031673-2019-00073
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 04/25/2019

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-360
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1