MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number B23858

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and found a previously addressed leak had burnt the sample access module (sam) board.The fse replaced the board resolving the issue.The repairs were verified as per service procedures.The dxh800 and dxh600 is compliant with the following safety ratings: (b)(4) safety requirements for electrical equipment for measurement, control, and laboratory use, part 1: general requirements.(b)(4) (2nd edition) safety requirements for electrical equipment for measurement, control, and laboratory use - part 1: general requirements.(b)(4) safety requirements for electrical equipment for measurement, control, and laboratory use, part 2-081: particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes.(b)(4) safety requirements for electrical equipment for measurement, control, and laboratory use, part 2-101: particular requirements for in vitro diagnostic (ivd) medical equipment.(b)(4) safety requirements for electrical equipment for measurement, control, and laboratory use, part 1: general requirements.(b)(4) safety requirements for electrical equipment for measurement, control, and laboratory use, part 2-081: particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes.(b)(4) safety requirements for electrical equipment for measurement, control, and laboratory use, part 2-101: particular requirements for in vitro diagnostic (ivd) medical equipment.(b)(4).

Event Description

The customer reported a burning smell coming from the dxh600 instrument during normal instrument operation.There were sample access module sam) error messages reported by the customer at the time of the event.There was no smoke, sparks, arcing or flames reported by the customer.The fire department was not called and there was/was no death or injury as a result.There was no medical attention required by any operator.Erroneous patient results were not generated.There was no change or effect to patient treatment in connection to the event.

• Brand Name: UNICEL DXH 600 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, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 6156581
• MDR Text Key: 61892680
• Report Number: 1061932-2016-00983
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: B23858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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