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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 Device Sensing Problem (2917)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated and the fluid level sensor was found to be the cause of the reported complaint condition.The fluid level sensor was replaced and the console passed all operational verification tests.
 
Event Description
The report received states that the console displays the error message "air in bubble trap" repeatedly during use.The user continues to use the console by disabling the sensor.There were no reported patient complications.
 
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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
Manufacturer (Section G)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
Manufacturer Contact
tosan onosode
one allentown parkway
allen, TX 75002
9723326338
MDR Report Key9365905
MDR Text Key167920041
Report Number1649914-2019-00064
Device Sequence Number1
Product Code DTR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number5201260
Device Lot Number3397
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2019
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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