MAUDE Adverse Event Report: AGILENT TECHNOLOGIES INC. 405 LS WASHER

Model Number 405LS

Device Problems Fire (1245); Smoking (1585)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.A1-a6: not applicable.No patient involvement.

Event Description

Customer reported "the instrument suddenly started smoking." customer took the top off and saw a part inside the instrument caught fire and was producing flame.The instrument stopped smoking once turned off.The customer was able to complete patient testing.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.The investigation is ongoing, and a supplemental report will be provided when new pertinent information is received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Investigation conclusion: damage that matched the failures that occurred to the customer ssrs (relays) could not be reproduced.Ssrs were damaged, however the damage could only be produced at a minimum by shorting the pump fuse and seizing the pump (a double fault situation that would involve the user to knowingly alter the fusing of the system).The ssr failure does not appear to be a flaw in the product's design or usage.The ratings for the fuses used in the products are approximately 50% of the max rating recommended by the ssr manufacturer.Meaning the fuses are properly sized for use with the ssr.The results of the conducted tests showed that the product is adequately fused.All reasonable user-based fault conditions regarding the use of the waste system and pump failure modes were tested.No currents could be produced that would damage the ssr that wouldn't blow the fuse before damage could occur.The results of the conducted tests showed that the ssr could only be damaged by shorting the pump fuse and seizing the pump (a double fault situation that would involve the user to knowing alter the fusing of the system).It is a possibility that there is an issue with the customer's power system or perhaps damage due to a lightning strike.The product has met all of its compliance requirements for electrical fast transients, for surge immunity and user safety.Component failure.It may be possible that the ssr did not meet its specification over long term use.However, there have not been enough field failures to warrant further investigation of the issue.The customer is using an unapproved 0.2um inline vacuum filter.However, the impact of using the filter over the approved 1.0um filter is negligible in regards to this issue.The root cause could not be determined as the issue could not be reproduced.

Event Description

Customer reported "the instrument suddenly started smoking." customer took the top off and saw a part inside the instrument caught fire and was producing flame.The instrument stopped smoking once turned off.The customer was able to complete patient testing.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.The instrument was returned for in-house repair.Vacuum relay on main printed circuit board (pcb) was found to be burnt.The unit was cleaned, and main pcb was replaced.1170204 1.47 software downloaded.The instrument has been calibrated and tested and is fully operational and available for use.The instrument is ready to be shipped back to customer site.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

Customer reported "the instrument suddenly started smoking." customer took the top off and saw a part inside the instrument caught fire and was producing flame.The instrument stopped smoking once turned off.The customer was able to complete patient testing.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.The instrument was returned for in-house repair.Vacuum relay on main printed circuit board (pcb) was found to be burnt.The unit was cleaned, and main pcb was replaced.1170204 1.47 software downloaded.The instrument has been calibrated and tested and is fully operational and available for use.The instrument is ready to be shipped back to customer site.The investigation to determine root cause is ongoing, and a supplemental report will be provided when new pertinent information is received.

• Brand Name: 405 LS WASHER
• Type of Device: 405 LS WASHER
• Manufacturer (Section D): AGILENT TECHNOLOGIES INC.; 5301 stevens creek blvd.; santa clara CA 95051
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 18367375
• MDR Text Key: 331019094
• Report Number: 0002916205-2023-00002
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 05700574033880
• UDI-Public: 05700574033880
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

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: 405LS
• Device Catalogue Number: 405LSR-SI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/15/2024; 03/06/2024
• Supplement Dates FDA Received: 02/12/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2019
• 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