MAUDE Adverse Event Report: MIABECKMAN COULTERMI DISCRETE MFG IO UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND

Device Problem Fire (1245)

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

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

The bec safety compliance engineer found that an assessment of the potential hazard could not be made because the fire initiated at the ups itself and it is not a beckman coulter product.Additionally, it was confirmed by the field service engineer (fse) that the fire was contained to the ups and did not affect the instrument or lab.The fse replaced the power cords to the dxh 900 instrument as a preventive measure.The ups was repaired by the company responsible for the ups and its functionality.Bec internal identifier - (b)(4).

Event Description

The customer reported the ups for the dxh900 hematology instrument shorted and caught fire.The customer used the laboratory fire extinguisher to contain the flames, firefighters were called but the fire had already been extinguished, they advised the customer not to use the ups.The ups was turned off and the equipment power cables disconnected.There was no report of injury or exposure as a result fo this event.Patient results were no impacted.

• Brand Name: UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): MIABECKMAN COULTERMI DISCRETE MFG IO; 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: 15688267
• MDR Text Key: 302558662
• Report Number: 1061932-2022-00067
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)211206
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• 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