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

Model Number 5201260

Device Problems Electrical /Electronic Property Problem (1198); Defective Component (2292)

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

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to quest medical for evaluation.A follow-up medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding an alleged issue encountered with the console.The report states that the console displayed ec179 during bypass.The console was swapped out and the case was resumed.There were no patient complications.

Manufacturer Narrative

The console was evaluated and the resistor in the motor driver board was identified as the cause of the reported issue.The motor driver board was replaced and the console passed all operational verification tests.

• 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: 10674376
• MDR Text Key: 213199104
• Report Number: 1649914-2020-00036
• 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

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5201260
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1