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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 TRAUMA FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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SMITHS MEDICAL ASD, INC. LEVEL 1 TRAUMA FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Model Number H-1025
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that the circulating water leaks from the base of the waste fluid cock.Event occurred before patient use.There was no patient involvement and no patient harm/adverse event reported.
 
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Brand Name
LEVEL 1 TRAUMA FAST FLOW FLUID WARMER
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18886327
MDR Text Key337488743
Report Number3012307300-2024-01282
Device Sequence Number1
Product Code BSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
BK940056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberH-1025
Device Catalogue NumberH-1025JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2024
Date Manufacturer Received02/14/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/05/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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