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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 2 CONSOLE RENTAL; CPBP HEAT EXHANGER

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QUEST MEDICAL, INC. MPS 2 CONSOLE RENTAL; CPBP HEAT EXHANGER Back to Search Results
Model Number 5201260RT
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
The console will be evaluated when it is received and 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 mps console.The report states that during delivery of the first dose, the console displayed the error message "internal error".The console was removed from service and will return to quest medical for evaluation.There were no patient complications.
 
Manufacturer Narrative
Mps console was received and decontaminated.Upon power up, the console did not fail.This was repeated a few times to ensure that there was nothing to find wrong with the console.However, upon attempting to read the console's log data (through the use of the log data utility software via the rs-232 port connection), error code ec060 (health check error) was displayed.The log data was found to be corrupted and thus not available for review.The log data was deleted, which cleared the error code.The console successfully passed the operational verification testing.
 
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Brand Name
MPS 2 CONSOLE RENTAL
Type of Device
CPBP HEAT EXHANGER
Manufacturer (Section D)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
MDR Report Key10759913
MDR Text Key215098370
Report Number1649914-2020-00037
Device Sequence Number1
Product Code DTR
Combination Product (y/n)N
PMA/PMN Number
K173716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/16/2020
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 Number5201260RT
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/29/2020
Supplement Dates Manufacturer Received10/01/2020
Supplement Dates FDA Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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