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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 NameEQUATOR
Type of DeviceSYSTEM, 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
Date FDA Received02/10/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEQ-5000
Was Device Available for Evaluation? No Answer Provided
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
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/10/2017 Patient Sequence Number: 1
Treatment
DISPOSABLE BLANKET IS USED IN CONJUNCTION WITH THI
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