MAUDE Adverse Event Report: BECKMAN COULTER FC 500 FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number	TN FC500 FLOW CYTOMETER 100-240V 50/60HZ
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was on site and confirmed what the customer reported.To resolve the issue the fse reinstalled power supply cart, verified instrument functionality.The bec compliance engineer assessed the event and provided the following assessment: based on the information and pictures provided via e-mail, it appears that any flaming was contained within the metal enclosure of the power supply cart.There does not appear to be any evidence of electrical hazard external to the cart itself.Therefore, the assessment is that no hazard was presented.Bec internal identifier - case (b)(4).
Event or Problem Description
The customer reported hearing a popping electrical noise on their fc 500 flow cytometer.The unit (power supply cart) caught fire as it sat idle.The customer reported seeing flames that were put out with a fire extinguisher.There was no direct harm to laboratory or laboratory personnel.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: FC 500 FLOW CYTOMETER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16799586
• Report Number: 1061932-2023-00090
• Device Sequence Number: 6377772
• Product Code: GKZ
• UDI-Device Identifier: 15099590572839
• UDI-Public: (01)15099590572839(11)180921
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K071681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: TN FC500 FLOW CYTOMETER 100-240V 50/60HZ
• Device Catalogue Number: 626553
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown