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

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.

• 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 Key: 5250900
• MDR Text Key: 32169989
• Report Number: 1061932-2015-01752
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• 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 Number: B24802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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