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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. LEVEL 1 FLUID WARMER SYSTEM, THERMAL REGULATING 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  Injury  
Manufacturer Narrative
Foreign: (b)(6).
 
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 DeviceSYSTEM, THERMAL REGULATING
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
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key11008866
MDR Text Key221452406
Report Number3012307300-2020-19953
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeTC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
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?
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

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