MAUDE Adverse Event Report: AGILENT TECHNOLOGIES INC. BIOTEK 405 TS WASHER

Model Number 405TS

Device Problem Smoking (1585)

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

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is currently ongoing.No additional information has been made available.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.A1-a6: patient information has not been provided by the user.

Event Description

Customer from germany reported a problem with biotek 405 ts washer.The device produced smoke when operated.The cause of this issue has not yet been found.The smoke stopped after switching off the instrument.Currently the instrument is not working.No direct or indirect patient harm or user harm have been reported.

Event Description

The customer reported a problem with biotek 405 ts washer.The device produced smoke when operated; the customer confirmed the following "during maintenance program there was a stranger smell".The smoke stopped after switching off the instrument.Additional information was received that the field service engineer (fse) found the ultrasonic unit defective.The fse replaced the ultrasonic unit and the two seals.The buffer switching and evaluation test performed.The ultrasonic test was carried out for 50 minutes.The device is working properly.The customer is able to continue patient testing.No direct or indirect patient harm or user harm have been reported.

Manufacturer Narrative

A1:, a6: patient information has not been provided by the user.

Manufacturer Narrative

Correction to manufacturer registration number, correct number is 2916205.

• Brand Name: BIOTEK 405 TS WASHER
• Type of Device: BIOTEK 405 TS WASHER
• Manufacturer (Section D): AGILENT TECHNOLOGIES INC.; 5301 stevens creek blvd.; santa clara CA 95051
• Manufacturer (Section G): SHANDON DIAGNOSTICS LIMITED; tudor road; manor park; runcorn, WA7 1 TA; UK WA7 1TA
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 17316839
• MDR Text Key: 319446938
• Report Number: 3003423869-2023-00085
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 05700574034061
• UDI-Public: 05700574034061
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

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: 405TS
• Device Catalogue Number: 405TSRVS-SI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/26/2023; 07/26/2023
• Supplement Dates FDA Received: 10/11/2023; 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1