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

Model Number PRO-TF300

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2016

Event Type  malfunction  

Event Description

Transcript of complaint as told by end user by phone: this is (b)(6).We have a non-contact thermometer.It's not working.It became so hot that you couldn't touch it.The batteries almost burned our hands and i need it replaced.It's still new.We just bought it.The device was returned to thermomedics for analysis but the end user discarded the batteries prior to return.The plastic battery door showed distortion indicative of an overheated battery.Batteries supplied are 2 x aa alkaline batteries.

Manufacturer Narrative

This is supplemental report #1 and contains the final evaluation of the subject device.The device was submitted to the manufacturer to determine the root cause of the overheated batteries.The evaluation was completed and received by our facility on jan.8, 2017.The summary and conclusion is attached to this submission.The device was tested and turned on and functioned normally.We were unable to reproduce the overheating of batteries.The end user's batteries were not returned with the device.Note that lithium-ion batteries are not used in this device.The manufacturer stated that solder which could become dislodged due to dropping could theoretically cause the intermittent malfunction.However, none was found and this cause is pure speculation as we have never encountered a device with loose solder.It is noted that the manufacturer performs a standby current test on each circuit board which would rule out a short circuit leading to overheating.The manufacturer will closely monitor this situation for recurrence.No medical intervention was necessary as a result of this incident.This concludes the investigation of the device.

Event Description

This is supplemental report #1.

• Brand Name: CAREGIVER 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; TW 24888 TW
• Manufacturer Contact: gary ohara ; 18310 calle la serra; rancho santa fe, CA 92091 ; 8587791060
• MDR Report Key: 6077100
• MDR Text Key: 59513198
• Report Number: 3008872366-2016-00001
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Assistant
• Device Model Number: PRO-TF300
• Device Catalogue Number: PRO-TF300
• Device Lot Number: 1514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE - NO FURTHER USE OF DEVICE