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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 Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A filed service engineer from quest will visit the user facility to evaluate the device.A follow-up medwatch will be submitted if additional information becomes available.
 
Event Description
A report was received regarding an alleged issue encountered during use of the console.The report states that the vent valve pops repeatedly during cases when there is no air in the heat exchanger to be expelled or high pressure to be relieved.There were no 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 Key9500916
MDR Text Key190528742
Report Number1649914-2019-00071
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 12/19/2019
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2019
Initial Date FDA Received12/20/2019
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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