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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 Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned to quest medical for evaluation.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 during the 2nd maintenance dose the console displayed ec004.The user tried several power cycles without being able to get past the issue.There were no reported 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 onosode
one allentown parkway
allen, TX 75002
9723326338
MDR Report Key8446289
MDR Text Key139823091
Report Number1649914-2019-00019
Device Sequence Number0
Product Code DTR
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 03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number5201260
Device Lot Number3414
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/14/2019
Initial Date FDA Received03/22/2019
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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