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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number L1-CW-220V
Device Problems Product Quality Problem (1506); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the heaters on the level 1 convective warmer were charred/burned. No patient injury or complications were reported in relation to this event.
 
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Brand NameLEVEL 1 CONVECTIVE 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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11649483
MDR Text Key244906712
Report Number3012307300-2021-03069
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue 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 Received03/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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