MAUDE Adverse Event Report: UNKNOWN AXILLARY THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number MFG # AMDC-412-00

Device Problems Failure To Adhere Or Bond (1031); Unable to Obtain Readings (1516)

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

Event Date 03/03/2017

Event Type  malfunction  

Event Description

A new axillary thermometer was not accurately registering a temperature ¿ despite having a good seal skin to skin.Unable to take po temps on medical icu (micu) for many patients sec to mechanical ventilation.Axillary is not accurate for some patients.Some you cannot get a good seal of skin to skin.There is then no other way to obtain an accurate temperature.

• Brand Name: AXILLARY THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6485051
• MDR Text Key: 72543502
• Report Number: 6485051
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: MFG # AMDC-412-00
• Other Device ID Number: ITEM #127837
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR