MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. AQUIOS CL FLOW CYTOMETRY SYSTEM; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	TN,AQUIOS CL
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information available reasonably suggests that the event was not a result of a malfunction of the aquios cl instrument.The event was caused by a fault from the facility supply circuit to the instrument and the specialist received a shock when touching the instrument due to the exposure to line voltage.Although the event was not a direct result of a beckman coulter device malfunction, bec is submitting a report in an abundance of caution.Bec internal identifier - (b)(4).
Event or Problem Description
There was a loss of ground resulting in an electrical shock to a technical support specialist who was assisting the field service engineer during troubleshooting on an aquios cl.The technical support specialist did not require medical attention as a consequence of the event.

• Brand Name: AQUIOS CL FLOW CYTOMETRY SYSTEM
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 10256065
• Report Number: 1061932-2020-00112
• Device Sequence Number: 2842517
• Product Code: OYE
• UDI-Device Identifier: 15099590225889
• UDI-Public: (01)15099590225889(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K141932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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: TN,AQUIOS CL
• Device Catalogue Number: B30166
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1