MAUDE Adverse Event Report: THERMOMEDICS, INC. CAREGIVER NON-CONTACT PROFESSIONAL THERMOMETER; INFRARED NON-CONTACT THERMOMETER

Model Number PRO-TF300

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2017

Event Type  malfunction  

Event Description

On 10/6/2017 user (b)(6) of (b)(6).Reported that the thermometer and batteries overheated while not being used.She uninstalled batteries.It was not being used on a patient.On 10/17/2017 received device, ser (b)(4) e.Tether attachment pin is missing.Case appears to have been dropped.On 10/18/2017 spoke with (b)(6): she said clinical coordinator reported batteries "got warm" (not hot) while not in use.On 10/18/2017 investigation begins.Initial test result: unable to replicate the overheating with new batteries.Device tested for proper operation and found to meet specification except for missing tether pin which does not affect operation.No overheating of the batteries found.2 x aa (b)(4) were returned.These were labeled #1 and #2.#1 voltage= 1.467 v.#2 voltage= 1.494 v.This voltage is normal and sufficient for normal operation.No distortion of the device battery compartment or battery door found.

• Brand Name: CAREGIVER NON-CONTACT PROFESSIONAL THERMOMETER
• Type of Device: INFRARED NON-CONTACT THERMOMETER
• Manufacturer (Section D): THERMOMEDICS, INC.; 18310 calle la serra; rancho santa fe CA 92091
• Manufacturer (Section G): TAIDOC TECHNOLOGY; 6f, no. 127 wugong 2nd rd.; 24888 wugu dist.; new taipei city, taiwan 24888 ; TW 24888
• Manufacturer Contact: gary ohara ; 18310 calle la serra; rancho santa fe, CA 92091 ; 8587791060
• MDR Report Key: 6996843
• MDR Text Key: 91960763
• Report Number: 3008872366-2017-00002
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nursing Assistant
• Device Model Number: PRO-TF300
• Device Catalogue Number: PRO-TF300
• Device Lot Number: 1450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 30 MO
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1