MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 09H39-01

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2019

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 reported that the cell-dyn emerald analyzer would not turn on and that the power cord was hot to the touch.Upon turning the unit on, there was visible smoke and sparks from the power plug.There was no user injury or impact to patient management reported.

Manufacturer Narrative

The field service representative (fsr) observed that cell-dyn emerald power adapter tip was melted due to overheating causing the instrument not to power on.Replacing the power adapter resolved the issue.Return testing was not completed as returns were not available.A review of the service history for the cell-dyn emerald revealed no additional issues were reported post cleaning of the parts.A review of tracking and trending did not identify any trends for the cell dyn emerald, serial number (sn) (b)(4), the emld us cord (list number (ln) 09h54-06) or the switching adapter, part number 8701689601.Labeling was reviewed and contains adequate information on hazard, safety, how to minimize potential harm to personnel, and precautions, such as wearing personal protective equipment.Based on the information within the complaint record no product deficiency was identified for the cell-dyn emerald, ln 09h39-01, sn (b)(4), emld us cord, ln 09h54-06, or the 70w switching adapter, part number 8701689601.

• Brand Name: CELL-DYN EMERALD ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 8704469
• MDR Text Key: 148192320
• Report Number: 2919069-2019-00067
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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