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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS DELIVERY SET W AA; CPBP HEAT EXCHANGER
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QUEST MEDICAL, INC. MPS DELIVERY SET W AA; CPBP HEAT EXCHANGER Back to Search Results
Model Number 5001102
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2014
Event Type  malfunction  
Event Description
Device 2 of 3.Ref: manufacturer reports 1649914-2014-00035, 00037.
 
Manufacturer Narrative
(b)(4).Quest medical, inc., has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Quest medical inc., defers to the pt's physician regarding medical history.
 
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Brand Name
MPS DELIVERY SET W AA
Type of Device
CPBP HEAT EXCHANGER
Manufacturer (Section D)
QUEST MEDICAL, INC.
allen TX
Manufacturer Contact
amy clendening-wheeler
one allentown pkwy.
allen, TX 75002
9723326338
MDR Report Key4013010
MDR Text Key21493156
Report Number1649914-2014-00036
Device Sequence Number1
Product Code DTR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/02/2017
Device Model Number5001102
Device Lot Number0463324M02
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/19/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received06/13/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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