MAUDE Adverse Event Report: MEDI-CHOICE DIGITAL THERMOMETER

Lot Number 1511SYO7A

Device Problems High Readings (2459); Device Displays Incorrect Message (2591)

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

Event Date 03/14/2016

Event Type  malfunction  

Event Description

Defective thermometers.This was straight out of the box in our supply room.The lot number (1511syo7a).Staff said they went through 12 different thermometers all of which produced a very high reading at first (108-112 degree f) and then read error.

• Brand Name: MEDI-CHOICE DIGITAL THERMOMETER
• Type of Device: DIGITAL THERMOMETER
• MDR Report Key: 5510751
• MDR Text Key: 40784421
• Report Number: MW5060948
• Device Sequence Number: 10
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/15/2016
• 12 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1511SYO7A
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other