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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FLUID WARMER THERMAL REGULATING THERMAL REGULATING SYSTEM

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SMITHS MEDICAL ASD, INC. LEVEL 1 FLUID WARMER THERMAL REGULATING THERMAL REGULATING SYSTEM Back to Search Results
Model Number L1-CW-220V
Device Problems Device Alarm System (1012); Pumping Stopped (1503)
Patient Problem Hypothermia (1915)
Event Date 01/01/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical heater automatically switched off when in used. The occlusion and service indication alarms went off. They reset the device per the manual but still the alarms remained. The device stopped warming and kept alarming. The patient got hypothermia as a result. No other adverse events reported.
 
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Brand NameLEVEL 1 FLUID WARMER
Type of DeviceTHERMAL REGULATING THERMAL REGULATING SYSTEM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
prime tower, business bay, p o
minneapolis, MN 55442
MDR Report Key11003113
MDR Text Key221271357
Report Number3012307300-2020-12343
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeAE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL1-CW-220V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/14/2020 Patient Sequence Number: 1
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