MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the reported issue by reviewing the error printouts.The fse was able to reproduce the complaint by attempting to turn on the instrument.The fse resolved the issue by replacing the main board.The data from the previous board was corrupted, therefore all alignments, settings and calibrations needed to be re-established.The instrument was validated by performing a quality control (qc).The qc results passed and was within published ranges.The aia-360 analyzer performed as intended and returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2019 through aware date (b)(6) 2020.There were no similar complaints identified during the search period.The aia-360 operator's manual under chapter 7- list of error messages states the following: error message: leak sensor s701 detected description: leakage sensor s701 activated troubleshooting: contact the service department.Error message: csum error (param) description: control parameter checksum error.Troubleshooting: turn the power off and on again and check the parameters.If this problem reoccurs, contact the service department.Error message: csum error (errorlog) description: error log checksum error.Troubleshooting: turn the power off and on again and check the parameters.If this problem reoccurs, contact the service department.Error message: csum error (operation list) description: operation log checksum error.Troubleshooting: turn the power off and on again and check the parameters.If this problem reoccurs, contact the service department.The most probable cause of the reported event is failure of main board.

Event Description

Customer reported a csum error 5029, 5032, 5033 along with a leak sensor error on the aia-360 analyzer upon startup.Customer observed dried salt in the dispensing well and then near what looks like an electrical piece.Customer did not see any liquid.The technical support specialist (tss) advised customer to clean off the salt debris.The tss also advised customer to swab the subfloor at both the s701 and s702 apertures.Customer was unable to find canned air.Customer indicated that she did not observe any liquid on the swab.The tss had customer disconnect and reconnect both sensors.Customer confirmed that the wash probe tubing was connected.Customer rebooted the aia-360 analyzer and got csum errors.The last preventative maintenance was performed on (b)(6) 2014.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting intact parathyroid hormone (ipth) patient samples.There was no indication of patient intervention or adverse health consequences due to the event.

• 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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10635014
• MDR Text Key: 228351892
• Report Number: 8031673-2020-00284
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

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: Health Professional
• Device Model Number: AIA-360
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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