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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE TRAUMA FAST FLOW SYSTEMS; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE TRAUMA FAST FLOW SYSTEMS; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Model Number 8002950
Device Problem Priming Problem (4040)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 trauma fast flow system is not detecting tubing for air.No adverse effects reported.
 
Manufacturer Narrative
Additional information was received indicating that the fault occurred during annual testing and not in use with a patient.One level 1® h-1200 fast flow fluid warmer was returned for analysis in fair condition.Functional testing performed by installing f-30 disposable filter onto h-31b air detector block 4, then powered on the device; unit powered on as intended.Based on the evidence, no fault was found as the complaint was not confirmed.
 
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Brand Name
SMITHS MEDICAL LEVEL 1 HOTLINE TRAUMA FAST FLOW SYSTEMS
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis, mn
MDR Report Key9801429
MDR Text Key182415991
Report Number3012307300-2020-01762
Device Sequence Number1
Product Code BSB
UDI-Device Identifier50695085829506
UDI-Public50695085829506
Combination Product (y/n)N
PMA/PMN Number
BK020043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8002950
Device Catalogue Number8002950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2020
Date Manufacturer Received03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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