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

Catalog Number 05342716001

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental mdr will be filed upon completion of the investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 308206955
• Report Number: 2028492-2022-00015
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1