MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3700 CS ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Model Number	02H30-01
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service inspected the analyzer cell-dyn 3700 cs analyzer and found a charred connector on the power supply module ac board.The replaced power supply assembly, list number 8921168202 consists of a pcb assy, power supply module, ac, part number 9601170.The connector j13 on the pcb assy, power supply module was found charred.Based on the application schematic diagram, a capacitor c21, part number 1502850 (kemet, (b)(4)) is placed between pin# 2 (ac line) and pin# 4 (ac neutral) to suppress the overvoltage while the power switch is turn on or off.Based on this information the smoke may be attributed to the probable cause as follows: the c21 experienced a dielectric breakdown in the device insulation due to the aging.As such, an excessive current was drawn from line to neutral of ac power to cause the burn to the power traces of j13 on the pcb board.The construction of the c21 employs a multi-layer metallized paper that is encapsulated and impregnated in self-extinguishing material meeting the requirements of ul 94v-0.Tracking and trending data associated with the part did not identify any trends associated with the complaint issue.Based on the available information and the complaint investigation, no systemic issue or deficiency of the cell-dyn 3700 cs analyzer was identified.
Event or Problem Description
Hold for jg 6/1/2020 the customer observed smoke from the back of the cell-dyn 3700 cs analyzer near the fan filter.The instrument was inspected and a charred connector was found on the power supply module ac board.No fire was observed.There were no injuries and no impact to patient management reported.

• Brand Name: CELL-DYN 3700 CS ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 10102933
• Report Number: 2919069-2020-00022
• Device Sequence Number: 3573428
• Product Code: GKZ
• UDI-Device Identifier: 00380740002688
• UDI-Public: 00380740002688
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K991605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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: 02H30-01
• Device Catalogue Number: 02H30-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1