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

Device Problem Installation-Related Problem (2965)

Patient Problem Injury (2348)

Event Date 05/21/2019

Event Type  Injury  

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 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
• Type of Device: 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: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 8730463
• MDR Text Key: 149064446
• Report Number: 1061932-2019-01672
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)171222
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN,DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other