MAUDE Adverse Event Report: BECKMAN COULTER TN DXH 600 HEMATOLOGY SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 600 HEMATOLOGY SYSTEM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the ups powervar connected to the dxh600 instrument caught fire with visible flames during normal instrument operation.The customer also reported the dxh600 was not affected by the event.However, the ups was destroyed.The laboratory was evacuated.The fire department was called.The fire department used a fire extinguisher to put out the fire.No injuries reported due to the event.There was no report of an injury or illness to the patient attributable to the output from the device in this event.No adverse event occurred.The failure mode is unknown.However, the issue was resolved by contacting the ups manufacturer, plugging the instrument and devices directly into a red outlet in the laboratory, powering off/on the analyzer and performing daily checks.
Additional Manufacturer Narrative
Section a patient information is not applicable.There was no impact to patients as a result of this event.The customer reported the ups powervar connected to the dxh600 instrument caught fire with visible flames during normal instrument operation.The customer also reported the dxh600 was not affected by the event.But the ups was destroyed.· the laboratory was evacuated.· the fire department was called.· the fire department used a fire extinguisher to put out the fire · no injuries reported due to the event.There was no report of an injury or illness to the patient attributable to the output from the device in this event.No adverse event occurred.The failure mode is unknown.However, the issue was resolved by contacting the ups manufacturer, plugging the instrument and devices directly into a red outlet in the laboratory, powering off/on the analyzer and performing daily checks.Bec internal identifier - (b)(4).

• Brand Name: TN DXH 600 HEMATOLOGY SYSTEM
• 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. kramer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 19958306
• Report Number: 1061932-2024-00011
• Device Sequence Number: 7064400
• Product Code: GKZ
• UDI-Device Identifier: 15099590192242
• UDI-Public: (01)15099590192242(11)161014
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• 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): 08/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: TN DXH 600 HEMATOLOGY SYSTEM
• Device Catalogue Number: B23858
• 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: 07/16/2024
• Initial Report FDA Received Date: 08/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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