MAUDE Adverse Event Report: COVIDIEN GENIUS; CLINICAL ELECTRONIC THERMOMETER

Model Number GENIUS 2

Device Problems Intermittent Continuity (1121); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2015

Event Type  malfunction  

Event Description

Since (b)(6) 2015, it was reported that 18 tympanic thermometers have had touch pad functionality issues, including the touch pad working sporadically and no touch pad functionality.The thermometers involved were taken out of service.Reportedly, no harm occurred to patients.

• Brand Name: GENIUS
• Type of Device: CLINICAL ELECTRONIC THERMOMETER
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• MDR Report Key: 5384983
• MDR Text Key: 36606408
• Report Number: 5384983
• 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: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Unknown
• Device Model Number: GENIUS 2
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1