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U.S. Department of Health and Human Services

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

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BECKMAN COULTER UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
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.
 
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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 Key6156581
MDR Text Key61892680
Report Number1061932-2016-00983
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120771
Number of Events Reported1
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 NumberB23858
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2016
Initial Date FDA Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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