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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS2 CONSOLE; CPBP HEAT EXCHANGER
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QUEST MEDICAL, INC. MPS2 CONSOLE; CPBP HEAT EXCHANGER Back to Search Results
Model Number 5201260
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
During annual preventive maintenance, the console was reported to have suddenly lost power while it was being installed.The device was not used on a patient.
 
Additional Manufacturer Narrative
The device was received and the reported complaint could not be duplicated.All connections were checked and no power loss was observed.The console passed all electrical and operational verification tests.The root cause of the alleged issue is unknown.
 
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Brand Name
MPS2 CONSOLE
Common Device Name
CPBP HEAT EXCHANGER
Manufacturer (Section D)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
MDR Report Key7248179
Report Number1649914-2018-00018
Device Sequence Number13707479
Product Code DTR
UDI-Device Identifier20634624521265
UDI-Public20634624521265
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K041979
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 05/18/2018
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
Operator of Device Other
Device Model Number5201260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/31/2018
Supplement Date Received by Manufacturer01/31/2018
Initial Report FDA Received Date02/07/2018
Supplement Report FDA Received Date05/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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