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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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ST PAUL LEVEL 1; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Model Number 8002950
Device Problem Pumping Problem (3016)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation in progress.
 
Event Description
It was reported that level 1 trauma fast flow systems (h-1200) exhibited low flow (failure to pump 1 gal/min).No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to design.The dhr review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.The device was manufactured in 2017.
 
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Brand Name
LEVEL 1
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10486455
MDR Text Key205453809
Report Number3012307300-2020-09007
Device Sequence Number1
Product Code BSB
UDI-Device Identifier50695085829506
UDI-Public50695085829506
Combination Product (y/n)N
PMA/PMN Number
H-1200
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8002950
Device Catalogue Number8002950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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