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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1

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SMITHS MEDICAL ASD, INC. LEVEL 1 Back to Search Results
Model Number L1-CW-220V
Device Problem Device Alarm System (1012)
Patient Problem No Patient Involvement (2645)
Event Date 07/02/2019
Event Type  malfunction  
Manufacturer Narrative
One level 1 blowe was returned for analysis. The hose was plugged in and the power cord was tested. It past the post. The technician pressed the amb button and the occlusion led flashed and alarmed. There were 2 sparks and 2 loud noises then it was immediately unplugged. The device emitted a burning smell. When it was opened up the device and noticed the heater connecter to the ac board was burned. The exit muffler and enclosure base had evidence of electrical burns. The technician replace the heater, blower assembly, ac distribution board, exit muffler, and enclosure base.
 
Event Description
Information was received indicating that a level 1 blower alarmed at the time of installation with out an ability to troubleshoot the issue. There was no patient involved.
 
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Brand NameLEVEL 1
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
new delhi
minneapolis, MN 55442
MDR Report Key10104037
MDR Text Key193032562
Report Number3012307300-2020-05361
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberL1-CW-220V
Device Lot Number001422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2020
Was Device Evaluated by Manufacturer? Yes
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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