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

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.

• Brand Name: LEVEL 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 Key: 10104037
• MDR Text Key: 193032562
• Report Number: 3012307300-2020-05361
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• 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 Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: L1-CW-220V
• Device Lot Number: 001422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/16/2020
• 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