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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem Missing Value Reason (3192)
Event Type  malfunction  
Event Description
It was reported that the level 1 hotline low flow system failed the electrical safety test.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
One fluid warmer was returned for evaluation.Visual inspection of the device found wear and tear damaged enclosure, front cover, tank cover and line cord, and an outdated pcb and power switch.A dhr review was performed subsequent to the manufacturing of the device and prior to its release; no problems or issues were identified during this dhr review.Device tank was filled with water and powered on.The reported customer complaint had been confirmed, the pcb board had high current draw.This was the result of a faulty pcb board; problem source determined to be the design.
 
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Brand Name
LEVEL 1 HOTLINE LOW FLOW SYSTEMS
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
MDR Report Key10026291
MDR Text Key189916573
Report Number3012307300-2020-03653
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberHL-390
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/06/2020
Initial Date FDA Received05/05/2020
Supplement Dates Manufacturer Received08/05/2020
Supplement Dates FDA Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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