MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC BENCHMARK ULTRA; SLIDE STAINER, AUTOMATED

Catalog Number	05342716001
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.A supplemental mdr will be filed upon completion of the investigation.
Event or Problem Description
A customer from china observed evidence of a damaged current sense printed circuit board (pcb) and cables on the benchmark ultra instrument.No evacuation needed.The part self-extinguished.No harm or injury alleged.
Additional Manufacturer Narrative
The issue was resolved by replacing the impacted components.Review of the provided images point to fluid dropping from the top level of the base plate of the instrument onto the impacted board.The fluid leak onto the connectors most likely caused thermal damage and melting of connectors, cables, and the affected board.The fluid leak most likely came from the slide drawer.The design of the benchmark ultra instrument limits the chances of the spread of fire due to limited fuel available (plastic) and the fact that it is mounted to metal.The instrument was designed to and has been certified to meet the standards of iec/en 61010-1 which include section 6, protection against electric shock, and section 9, protection against the spread of fire.Device code updated to circuit failure.

• Brand Name: BENCHMARK ULTRA
• Common Device Name: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; na; tucson AZ 85755
• Manufacturer Contact: timothy blair ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 9253534412
• MDR Report Key: 16026126
• Report Number: 2028492-2022-00015
• Device Sequence Number: 5476223
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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 Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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