MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 2 CONSOLE; CPBP HEAT EXHANGER

Model Number 5201260

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The console will be evaluated and a follow up medwatch will be submitted if additional information becomes available.

Event Description

A report was received stating that the delivery pressures displayed on the mps are not matching the pressures that the surgeon sees at the table.The report stated that the surgeon's team is having to flow at lower flow rates to compensate for the higher pressures being displayed on the mps.The console will return to quest medical for investigation/repair.

Manufacturer Narrative

The device was evaluated and the reported complaint condition could not be duplicated.The device was tested and successfully passed all operational verification testing.

• Brand Name: MPS 2 CONSOLE
• Type of Device: CPBP HEAT EXHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 11000713
• MDR Text Key: 222015396
• Report Number: 1649914-2020-00041
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• PMA/PMN Number: K173716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1