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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 Problem Display or Visual Feedback Problem (1184)
Patient Problem Insufficient Information (4580)
Event Date 11/20/2020
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 stating that the delivery pressures displayed on the mps are not matching the pressures that the surgeon sees at the table.The report stated that the surgeon's team is having to flow at lower flow rates to compensate for the higher pressures being displayed on the mps.The console will return to quest medical for investigation/repair.
 
Manufacturer Narrative
The device was evaluated and the reported complaint condition could not be duplicated.The device was tested and successfully passed all operational verification testing.
 
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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 Key11000713
MDR Text Key222015396
Report Number1649914-2020-00041
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 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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number5201260
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/20/2020
Initial Date FDA Received12/14/2020
Supplement Dates Manufacturer Received11/20/2020
Supplement Dates FDA Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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