MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 400 SERIES

Device Problems Fail-Safe Design Failure (1222); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2015

Event Type  malfunction  

Event Description

The probe's placement during surgery was in the stomach and not the esophagus.While the event itself was determined to be an operator error, intense analysis of the event finds the device is not well designed a would be improved if there were depth markings that could be used to guide/confirm placement.

• Brand Name: LEVEL 1
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd.; arden hills MN 55112
• MDR Report Key: 5497387
• MDR Text Key: 40243003
• Report Number: 5497387
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400 SERIES
• Device Catalogue Number: ES400-18
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2016
• 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 Number: 1
• Patient Age: 63 YR
• Patient Weight: 118