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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The console was evaluated and the vfd display was found to be non-functional.The vfd display was replaced and the console passed all operational verification tests.
 
Event Description
A report was received regarding an issue encountered with the console.The report states that the upper display works intermittently and when the user presses on the display, it comes back on.There were no patient complications resulting from the issue.
 
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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 eweka
one allentown parkway
allen, TX 75002
9723326338
MDR Report Key11287706
MDR Text Key242387599
Report Number1649914-2021-00002
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5201260
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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