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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number CON-HL-90
Device Problem Defective Component (2292)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 hotline low flow system has a micro switch issue, and a broken missing lever arm.No adverse effects reported.
 
Manufacturer Narrative
Device evaluation: one smiths medical level 1 hotline low flow system was returned for analysis with a broken micro switch.During analysis, the reported issue was duplicated.It was noted that forcing the disposable or temperature check on or off of the hot line device was the cause of the reported issue.Service replaced the broken micro switch to correct the reported issue.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be user interface.
 
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Brand Name
SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis, mn
MDR Report Key9945796
MDR Text Key187123515
Report Number3012307300-2020-02921
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 06/26/2020
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 Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2020
Initial Date Manufacturer Received 03/11/2020
Initial Date FDA Received04/09/2020
Supplement Dates Manufacturer Received04/16/2020
Supplement Dates FDA Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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