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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC. CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problems Contamination (1120); Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2023
Event Type  malfunction  
Manufacturer Narrative
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 there was no fault.The device requires an internal check as it was contaminated.There was patient involvement but there was no injury or harm.
 
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Brand Name
CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE
Type of Device
WARMER, THERMAL, INFUSION FLUID
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 Key18849474
MDR Text Key337328558
Report Number3012307300-2024-01165
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL-90
Device Catalogue NumberHL-90-INT-230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/11/2022
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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