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

Model Number	09H39-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed smoke from an electrical connection cable that was visibly burned on a cell-dyn emerald instrument.There was no harm to the user or impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available information was included.Additional details are not available.
Additional Manufacturer Narrative
The field service representative (fsr) found 70w switching power supply (8701689601) serial number (b)(6) connector to the cpu melted at both power supply and analyzer.The analyzer is down, and parts have been ordered.A review of all tickets associated with the 09h39-01 cell-dyn emerald analyzer, and a review for complaint trends for the list numbers were performed.The review did not identify any trends and the complaint activity was normal for the product.Additionally, labeling was reviewed and adequately addressed the issue.Based on the investigation, no systemic issue or deficiency was identified for the cell-dyn emerald, sn (b)(6).

• Brand Name: CELL-DYN EMERALD SYSTEM
• Common Device Name: 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: 15544079
• Report Number: 2919069-2022-00031
• Device Sequence Number: 5593854
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• PMA/510(K) Number: K081495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown