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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 H-1200 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION PRODUCT CODE: BSB
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SMITHS MEDICAL ASD, INC. LEVEL 1 H-1200 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION PRODUCT CODE: BSB Back to Search Results
Model Number 8002950
Device Problem Device Emits Odor (1425)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 h-1200 fast flow fluid warmer had an "burning smell".No adverse patient effects were reported.
 
Manufacturer Narrative
H3: one level 1 trauma fast flow systems was received in good physical condition.Visual inspection was completed.The device was powered on and it was noticed that the return tube had a crack causing water to get on the printed circuit board (pcb) which caused the burning smell.The reported issue was confirmed and was caused by a design issue.The cracked tube was replaced to resolve the issue.
 
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Brand Name
LEVEL 1 H-1200 FAST FLOW FLUID WARMER
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION PRODUCT CODE: BSB
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9168869
MDR Text Key163573298
Report Number3012307300-2019-05410
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 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
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 Manufacturer10/10/2019
Date Manufacturer Received02/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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