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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number HL-390
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2024
Event Type  malfunction  
Manufacturer Narrative
One device was received for investigation.The device was visually inspected and functionally tested.The lcd has liquid crystal leakage inside making 2/3 of it unreadable.The reported complaint is confirmed.The root cause is a force or impact to the lcd.After replacing the pcb which contains the lcd the device was functionally sound.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
 
Event Description
It was reported that they were unable to see temp clearly.There was no patient involvement and no patient harm/adverse event reported.
 
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER, 390
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 Key19105778
MDR Text Key340239793
Report Number3012307300-2024-02579
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10695085002796
UDI-Public(01)10695085002796(11)230321
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2024
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2023
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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