MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 1800 ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 07H77-01

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

No patient involvement, (b)(4).The evaluation included review of product historical data and product labeling.The review of the historical data did not identify any adverse trends or abnormal complaint activity.Inspection of the returned cell-dyn 1800 power supply did not show any burned component or burn traces.The returned power supply components are covered with excess dirt/dust.The condition indicated that the cell-dyn 1800 was not maintained well.The possibility of the excess dirt/dust getting heated inside the instrument and emitting the smoke could not be eliminated as the possible cause for the complaint incident.The cell-dyn 1800 operator's manual provides adequate information related to the complaint incident.Based on the evaluation, it was concluded that the issue was specific to the customer's cell-dyn 1800 analyzer not being properly maintained.No product issue was identified for the power supply assembly or cell-dyn 1800 analyzer.

Event Description

The account smelled smoke and saw sparks inside the cell-dyn 1800 while attempting to wake up the instrument from sleep mode.The account stated the operator pressed button for run/prime and saw sparks through the side vents of the cell-dyn 1800 analyzer.The operator turned off and unplugged the analyzer.The account also stated that 30 minutes prior to attempting to wake the analyzer, a cigar smoke smell was noticed in another room but this smell was not traced back to this analyzer.No operator injury was reported.

• Brand Name: CELL-DYN 1800 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: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5476807
• MDR Text Key: 39642053
• Report Number: 2919069-2016-00012
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07H77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1