MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN EMERALD SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number 09H39-01

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed smoke from outlet on the side of the instrument where the reagents are located on cell-dyn emerald analyzer.The customer smelled burnt smell.The screen of analyzer blacked out.There was no visible fire or spark.There was no patient involvement and no harm to user reported.

Manufacturer Narrative

During the site visit by the field service engineer (fse) inspected the analyzer and removed the cpu board, part number 8701686907 and visually inspected it and verified there were no damaged components or signs of fire.Cpu board was reinstalled, and instrument is up and running without any issues.There was no fire or smoke was seen nor any damage to the instrument.There was no injury to personnel reported.A review of the service history for the cell dyn emerald analyzer revealed no additional issues were reported.A review of tracking and trending did not identify any trends for the cell dyn emerald analyzer or cpu board.Based on the available information, no systemic issue or deficiency of the cpu board or the cell dyn emerald analyzer was identified.

• Brand Name: CELL-DYN EMERALD SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15462683
• MDR Text Key: 305277472
• Report Number: 2919069-2022-00029
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 09H39-01
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2011
• 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