MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC; BENCHMARK XT

Model Number 750-700

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fall (1848)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

The heater pads within the slide tray may be slightly loose which could cause drips on the floor.Fse tightened all the heater pads to prevent any drips.

Event Description

Lab staff fell due to liquid allegedly coming from underneath the instrument.Staff did not have to seek medical attention.

• Type of Device: BENCHMARK XT
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC; 1910 e innovation park dr; 1910 e innovation park dr; tucson AZ 85755 1962
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS, INC; 1910 e innovation park dr; none; tucson AZ 85755 1962
• Manufacturer Contact: tim giblin ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 5208777035
• MDR Report Key: 5693571
• MDR Text Key: 47503365
• Report Number: 2028492-2016-00003
• Device Sequence Number: 1
• Product Code: MYA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/01/2016

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
• Device Operator: Other Health Care Professional
• Device Model Number: 750-700
• Device Catalogue Number: 05265231001
• Other Device ID Number: UDI# 04015630981069
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 06/01/2016
• 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