MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS BENCHMARK ULTRA

Model Number 750-600

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fall (1848)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

Instrument malfunction: tub overflow occurred and allowed fluid to reach floor.Tub sensor(s) did not properly report error and prevent fluid leak.The following failure mode is same event reported in mdr-2028492-2016-00004-00 which caused serious slip and fall injury.

• Brand Name: BENCHMARK ULTRA
• Type of Device: BENCHMARK ULTRA
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS; 1910 e. innovation park dr.; tucson AZ 85755 1962
• Manufacturer Contact: tim giblin ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 5208777035
• MDR Report Key: 8229488
• MDR Text Key: 132570274
• Report Number: 2028492-2019-00001
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 750-600
• Device Catalogue Number: 05342716001
• Device Lot Number: 311423
• Date Manufacturer Received: 12/10/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1