MAUDE Adverse Event Report: BECKMAN COULTER ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM

Model Number 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

The fse replaced the pc6 and conducted unrelated preventive maintenance, the system was left fully operational.The fse was contacted and confirmed that the computer was not opened by them to assess the extent of the damage.The fse is arranging the return of the pc6 to beckman coulter for evaluation.Investigation is ongoing.(b)(4).

Event Description

The customer reported that was a fire in the computer tower for their iricell system.The iricell is composed of an ichem® velocity¿ automated urine chemistry system and an iq 200 urine analyzer.On 16-sep-2019, the customer called customer technical support (cts) to report that their iricell system pc6 computer caught fire and the fire department was called.The pc6 is used for both the ichem velocity and iq200 instruments.The customer confirmed that there was no injury to any laboratory personnel and that the lab did not suffer any damage as a result of the alleged fire.The customer stated to the field service engineer (fse) that the pc6 had caught fire internally and that it was blowing sparks/fire out of the fans and vents and that there was no damage observed as a result of this event.

Manufacturer Narrative

Follow up 01: the fse was contacted and it was confirmed that the computer was not opened by the fse and therefore, the extent of the damage or what components were affected was unknown.On october 16, 2019, the affected computer was received by the product compliance engineering department at beckman coulter for further analysis.From the pc6 evaluation, it was confirmed that the reported cpu fire, was actually an overheating of the dvd sata cable adapter.Additionally, the following conclusions were documented on report #(b)(4): no electrical hazard occurred as a result of this event.No external fire hazard occurred as a result of this event.No burn hazard occurred as a result of this event.There was some potential for contact with smoke precipitated by this event.The level of impact to a user or anyone near the device would likely depend on their sensitivity to smoke or the acrid odor of burning electronics.

Manufacturer Narrative

Follow up 02: remedial action: modification selected.Correction/removal report number was added.On 25-mar-2020, field action fa-000122 was initiated resulting in correction/removal report 2050012-03/25/2020-004c for this reported event.Bec internal identifier - (b)(4).

• Brand Name: ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER; lismeehan; o'callaghan's mills/co clare ; EI
• MDR Report Key: 9188461
• MDR Text Key: 162243100
• Report Number: 2122870-2019-01122
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751(11)NO-DATA
• Combination Product (y/n): N
• PMA/PMN Number: K171083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2050012-03/25/2020-004C
• Patient Sequence Number: 1