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

Catalog Number 723585

Device Problem Charred (1086)

Patient Problem Not Applicable (3189)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument.The fse found that the customer had connected the instrument plug that was defective and not compatible with the instrument specifications.This caused the cable plug to be burnt.The fse replaced the damaged cable.The repairs were verified by the fse.(b)(4).

Event Description

The customer reported the plug of the coulter lh 780 hematology analyzer was burnt when connected to an outlet.There was smoke reported by the customer.The fire department was not called and there was no death or injury as a result.There was no medical attention required by any operator.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

• 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 Key: 5752095
• MDR Text Key: 48303112
• Report Number: 1061932-2016-00574
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K061616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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