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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 SYSTEM; WARMER, THERMAL, INFUSION FLUID

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SMITHS MEDICAL ASD; INC. LEVEL 1 HOTLINE LOW FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that there was a switch issue to a smiths medical level 1® hotline® low flow system.There were no reported adverse effects.
 
Manufacturer Narrative
One level 1 hotline low flow systems - hl-90 was returned for analysis.The device was in very good condition.Testing started with filling up the tank with water and turning on the power switch.The reported issue of a "switch issue" was confirmed and was due to a bad micro switch assembly.The micro switch was replaced and the device was re-caliberated.
 
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Brand Name
LEVEL 1 HOTLINE LOW FLOW SYSTEM
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis,, mn
MDR Report Key9887345
MDR Text Key185192158
Report Number3012307300-2020-02161
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 06/15/2020
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-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2020
Initial Date Manufacturer Received 02/21/2020
Initial Date FDA Received03/27/2020
Supplement Dates Manufacturer Received04/16/2020
Supplement Dates FDA Received06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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