MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS GENIUS 2; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 303000

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/31/2017

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a thermometer.The customer states the tip is burnt.

• Brand Name: GENIUS 2
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almieda ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6368145
• MDR Text Key: 68762222
• Report Number: 3006451981-2017-05019
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 303000
• Device Catalogue Number: 303000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2017
• Date Device Manufactured: 12/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1