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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 BLOWER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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SMITHS MEDICAL ASD, INC. LEVEL 1 BLOWER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Catalog Number L1-CW-220V
Device Problem Device Emits Odor (1425)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical level 1 blower exhibited burnt smell during operation.There were no patient consequences in this event.No adverse effects were reported.
 
Manufacturer Narrative
One level 1 blower was returned for analysis.The analyst connected the mains cord and hosepipe and powered the device on.During visual inspection no burnt marks were found on exit muffler in and outer areas.Also, during visual inspection of heater no burnt marks were found in and outer areas.The heater also passed the resistance tolerance test.Device was checked approximately for one hour at all temperatures but the device failed to give a burn smell during operation.
 
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Brand Name
LEVEL 1 BLOWER
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key9938717
MDR Text Key187033361
Report Number3012307300-2020-02920
Device Sequence Number1
Product Code BSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberL1-CW-220V
Was Device Available for Evaluation? No
Date Returned to Manufacturer03/12/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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