MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS2 CONSOLE; CPBP HEAT EXCHANGER

Model Number 5201260

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return 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 with the mps 2 console.The report states that the console lost power after prime but before the case started.The device was not used on a patient.

Manufacturer Narrative

The device was evaluated and the complaint was duplicated.The power supply was identified as the cause of the issue reported.The power supply was replaced and the console passed all operational verification tests.

• Brand Name: MPS2 CONSOLE
• Type of Device: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen, tx
• MDR Report Key: 9970558
• MDR Text Key: 190530093
• Report Number: 1649914-2020-00023
• 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
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

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
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1