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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

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BECKMAN COULTER UNICEL DXH 800 CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
Catalog Number B24802
Device Problem Charred (1086)
Patient Problem Not Applicable (3189)
Event Date 11/02/2015
Event Type  malfunction  
Manufacturer Narrative
The fse found that the printed circuit board had burnt out.The fse replaced the circuit board, which resolved the temperature issues.The repairs were verified per established procedures.The beckman coulter internal identifier for this event is (b)(6).
 
Event Description
The customer reported the unicel dxh 800 cellular analysis system was generating temperature errors.The field service engineer (fse) found that the printed circuit board (pcb) had burnt out.There were no sparks, arcs, flames, or smoke observed.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.
 
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Brand Name
UNICEL DXH 800 CELLULAR ANALYSIS SYSTEM
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECKMAN COULTER
250 south kraemer blvd.
brea CA 92821
Manufacturer (Section G)
BECKMAN COULTER
11800 sw 147th ave
miami FL 33196
Manufacturer Contact
miranda holland
11800 sw 147th ave
32-s08
miami, FL 33196
3053802031
MDR Report Key5250900
MDR Text Key32169989
Report Number1061932-2015-01752
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K140911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Medical Technologist
Type of Report Initial
Report Date 11/02/2015
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 NumberB24802
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2015
Initial Date FDA Received11/25/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
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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