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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

The fse has returned parts impacted and there is an ongoing investigation to determine what is the failure that caused event.In addition, it has been decided to remove and replace the velocity instrument from customer site.The ichem velocity complies with the following standards for product safety; ul 61010-1:2012 ed.3+r:29 - safety requirements for electrical equipment for measurement, control, and laboratory use ¿ part 1: general requirements.Ul 61010-2-101 issued: 2015/08/14 ed: 2 - safety requirements for electrical equipment for measurement, control, and laboratory use ¿ part 2-101: particular requirements for in vitro diagnostic (ivd) medical equipment ul 61010-2-081:2015 ed.2 - safety requirements for electrical equipment for measurement, control and laboratory use - part 2-081: particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes csa c22.2#61010-1-12:2012 ed.3+u1;u2 - safety requirements for electrical equipment for measurement, control, and laboratory use ¿ part 1: general requirements (r2017) csa c22.2#61010-2-101:2015 ed.2 - safety requirements for electrical equipment for measurement, control, and laboratory use ¿ part 2-101: particular requirements for in vitro diagnostic (ivd) medical equipment csa c22.2#61010-2-081:2015 ed.2 - safety requirements for electrical equipment for measurement, control and laboratory use - part 2-081: particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes the investigation is ongoing.Bec internal identifier - (b)(4).

Event Description

The customer reported a burning smell coming from their ichem® velocity¿ automated urine chemistry system.There was no injury reported, the fire department was not called, no evacuation of the lab occurred, and no erroneous results were generated during the event.The field service engineer (fse) was onsite and while troubleshooting the instrument, found evidence that a fire had taken place within the instrument.The fire occurred in the air gap harness, melting the wire connectors and zip ties that hold it in place.

• 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
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine dr.; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12243122
• MDR Text Key: 266004639
• Report Number: 2122870-2021-00114
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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