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

Model Number 5201260

Device Problems Defective Component (2292); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.A follow up medwatch will be filed if additional information is available.

Event Description

A report was received regarding an alleged issue with the mps console.The report states that the console displayed "internal error".The console was power cycled several times with the error displaying each time it was powered on.No patient complications were reported.

Manufacturer Narrative

An investigation of the suspect console could not duplicate the reported condition.Quest will continue to monitor complaint trends.Quest has concluded the investigation.

Event Description

A report was received regarding an alleged issue with the mps console.The report states that the console displayed "internal error".The console was power cycled several times with the error displaying each time it was powered on.No patient complications were reported.

• Brand Name: MPS 2 CONSOLE
• Type of Device: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 11532222
• MDR Text Key: 260238954
• Report Number: 1649914-2021-00004
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1