• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER - 100 VOLT CONFIGURATION SYSTEM, THERMAL REGULATING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER - 100 VOLT CONFIGURATION SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number L1-CW-100V
Device Problem Device Alarm System (1012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
Only the month ((b)(6)) and year (2020) of the event date are known. Customer facility phone number: (b)(6). Company representative phone number: (b)(6).
 
Event Description
It was reported that during the use of the product, the maintenance indicator turned on. No patient injury or complications were reported in relation to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEVEL 1 CONVECTIVE WARMER - 100 VOLT CONFIGURATION
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
aichi pref
minneapolis, MN 55442
MDR Report Key10937040
MDR Text Key219310783
Report Number3012307300-2020-12038
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeJA
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 12/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberL1-CW-100V
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 Received11/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-