MAUDE Adverse Event Report: COVIDIEN; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/03/2016

Event Type  malfunction  

Event Description

Patient's temperature was taken orally (in oral mode).Temperature was read by the machine as 101.8.Because patient did not appear to have a fever, another machine was obtained which read the temperature as 97.0.The nurse checked her temp with the faulty machine and it showed her temp at 101.5.

• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): COVIDIEN; 5870 stoneridge drive, suite 6; pleasanton CA 94588
• MDR Report Key: 6128595
• MDR Text Key: 60920266
• Report Number: 6128595
• 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: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2016
• 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: 4 YR