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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 EQUATOR BLOWER; SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD, INC. LEVEL 1 EQUATOR BLOWER; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number CON-EQ-5000
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the level 1 equator blower had a bad lcd screen.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Cover page was updated with correct hazard code as wrong product was reported.Convective warming|level 1 equator blowers not level one warming.
 
Event Description
Complaint of bad lcd was on convective warming|level 1 equator blowers not level one warming devices.Corrected cover page hazard code.
 
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Brand Name
LEVEL 1 EQUATOR BLOWER
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
MDR Report Key11664281
MDR Text Key245351019
Report Number3012307300-2021-03105
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCON-EQ-5000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/17/2021
Initial Date FDA Received04/14/2021
Supplement Dates Manufacturer Received04/29/2021
Supplement Dates FDA Received05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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