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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 2 CONSOLE; CPBP HEAT EXHANGER
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QUEST MEDICAL, INC. MPS 2 CONSOLE; CPBP HEAT EXHANGER Back to Search Results
Model Number 5201260
Device Problems Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
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 regarding an alleged issue encountered with the console.The report states that the console displayed ec179 during setup.The console was power-cycled several times before removing from service.Mps console will return to quest for repair.No patient complications were reported.
 
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.
 
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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 Key11000317
MDR Text Key221825725
Report Number1649914-2020-00040
Device Sequence Number1
Product Code DTR
Combination Product (y/n)N
PMA/PMN Number
K173716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/15/2021
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 Number5201260
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/16/2020
Initial Date FDA Received12/13/2020
Supplement Dates Manufacturer Received11/16/2020
Supplement Dates FDA Received01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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