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

Model Number 5201260

Device Problem Defective Component (2292)

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

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

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 a case.The console was swapped out and there were no patient complications.

• Brand Name: MPS 2 CONSOLE
• Type of Device: CPBP HEAT EXHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: hassaan hashmi ; one allentown parkway; allen, TX 75002
• MDR Report Key: 10605957
• MDR Text Key: 226109521
• Report Number: 1649914-2020-00035
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2020

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: No Information
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1