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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

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BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Catalog Number 723585
Device Problem Charred (1086)
Patient Problem Not Applicable (3189)
Event Date 09/21/2015
Event Type  malfunction  
Manufacturer Narrative
The fse found that the diluter 2 card had malfunctioned and burnt out charring some components.The fse replaced the card, which repaired the burning smell and the errors.The repairs were verified per established procedures.(b)(6).
 
Event Description
The field service engineer (fse) reported a burning smell from the coulter lh 780 hematology analyzer when servicing the instrument.The instrument was generating probe wipe obstruction errors when the burning smell was noticed.There were no sparks, arcs, flames or smoke observed and the fire department was not called.The fse was wearing personal protective equipment (ppe) consisting of gloves, eye protection and a laboratory coat at the time of the occurrence.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.
 
Manufacturer Narrative
The device manufacture date was changed from 02/01/2015 to 02/01/2008.
 
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Brand Name
COULTER LH 780 HEMATOLOGY ANALYZER
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 Key5158027
MDR Text Key28563415
Report Number1061932-2015-01596
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061616
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 Followup
Report Date 09/21/2015
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 Number723585
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2008
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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