MAUDE Adverse Event Report: MEDICHOICE OWENS AND MINOR MEDICHOICE DIGITAL THERMOMETER

Model Number 916821

Device Problems Detachment Of Device Component (1104); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Material Separation (1562)

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

Event Date 10/30/2016

Event Type  malfunction  

Event Description

Numerous infant digital thermometers that have blue caps are either not functioning when activated or when try to remove from case the blue cap comes off.Noted before patient use.No patient information needed.

• Brand Name: MEDICHOICE DIGITAL THERMOMETER
• Type of Device: THERMOMETER
• Manufacturer (Section D): MEDICHOICE OWENS AND MINOR; mechanicsville VA 23116
• MDR Report Key: 6098989
• MDR Text Key: 59906668
• Report Number: MW5065976
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 916821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1