MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While installing the instrument the fse injured his hand.The flap behind the floor stand (compressor side) of the instrument was jammed and opened jerkily.The fse was able to complete the instrument install process.Bec internal identifier - (b)(4).
Event or Problem Description
In the process of installing the dxh 900 hematology instrument at the customer site, the field service engineer (fse) injured the index finger on his left hand when a flap in the rear area of the instrument opened jerkily.The fse was treated by a doctor.The hand was x-rayed and the finger was found to be bruised and fractured.The injury did not require stitches but the finger was stabilized with a rail/splint.

• Brand Name: UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 8730463
• Report Number: 1061932-2019-01672
• Device Sequence Number: 2003762
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)171222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TN,DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other