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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EQUATOR; SYSTEM, THERMAL REGULATING
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SMITHS MEDICAL ASD, INC. EQUATOR; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number EQ-5000
Device Problem Temperature Problem (3022)
Patient Problem Erythema (1840)
Event Date 01/05/2017
Event Type  malfunction  
Event Description
Equator 5000 forced air warmer was being used on a patient during operative procedure.Certified nurse anesthetist(crna)using the device set the device temperature for 44 degrees (celsius).Crna noted that the reading on device was only 17 degrees, machine was turned off and tubing repositioned.After 7-10 minutes, noted that reading was still at 17 degrees and that the tubing from the machine was very hot.Warmer use was then discontinued.Noted small areas of redness on patient's chest and forearms.Cool cloths applied to affected areas.Air warmer given to clinical engineering dept.Disposable blanket, however, was already discarded and disposed into trash compactor.
 
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Brand Name
EQUATOR
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6321762
MDR Text Key67111883
Report Number6321762
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberEQ-5000
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2017
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer01/06/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
DISPOSABLE BLANKET IS USED IN CONJUNCTION WITH THI
Patient Outcome(s) Other;
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