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 09/22/2017

Event Type  malfunction  

Event Description

On (b)(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 (b)(6) 2017 thermomedics called (b)(6) - left message.On 9/25/2017 thermomedics spoke with (b)(6).She said batteries overheated but no injury resulted from the overheated batteries.The thermometer was not turned on or being used on a patient at the time.They had replaced original batteries with (b)(6) industrial alkaline aa batteries.Thermomedics sent out ups label with instructions for her to send in the device and batteries.On 10/3/2017 thermomedics receives device and batteries.Initial test result: unable to replicate the overheating with new batteries.Device meets specification.One of the returned batteries shows signs of leakage.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: 6958414
• MDR Text Key: 90555982
• Report Number: 3008872366-2017-00001
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• 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: 1448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2014
• 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