MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 81-020409

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/05/2020

Event Type  malfunction  

Event Description

Temperature probe was found in the right mainstem bronchus during a transesophageal temp monitoring.

• Brand Name: DEROYAL
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 10282352
• MDR Text Key: 199066863
• Report Number: 10282352
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 81-020409
• Device Catalogue Number: 81-020409
• Device Lot Number: 61377975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 78