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 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Conclusion: i, (b)(6), ms elect.Eng., have completed an electrical analysis and could find no problem with the returned device.The biomed tech at the user facility, (b)(6), couldn't find one either.This is the first incident of this issue - overheating batteries.We will continue the investigation by attempting to recreate the issue and the device will be sent to the manufacturer for further investigation.

Event Description

Nurse noticed thermometer was getting increasingly hotter and took the thermometer to the nurses station.The plastic battery door showed signs of melting.Staff contacted biomed and device eventually cooled off when the biomed tech arrived a few minutes later.

Manufacturer Narrative

This is supplemental report #1 and contains 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 finished on oct.16, 2015.The report concludes that the only scenario that could reproduce sufficient overheating to deform the plastic case was an internal short circuit of the battery itself.The device did not present a short circuit to the batteries so the most likely cause was one of the 2 batteries.Had an intermittent short circuit.The procell batteries returned with the device were depleted so it was not possible to recreate the overheating with those batteries.Overheating was recreated by short circuiting fresh batteries.This concludes the investigation of the device and no remedial action is required as it is determined that the cause of the overheating was not 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 0000
• Manufacturer (Section G): TAIDOC TECHNOLOGY; 6f, no. 127 wugong 2nd rd.; 24888 wugu dist.; new taipei city 24888 ; TW 24888
• Manufacturer Contact: gary ohara ; 18310 calle la serra; rancho santa fe, CA 92091 ; 8587791060
• MDR Report Key: 5159644
• MDR Text Key: 28703468
• Report Number: 3008872366-2015-00001
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/01/2015,11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PRO-TF300
• Device Catalogue Number: PRO-TF300
• Device Lot Number: 11452
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2015
• Distributor Facility Aware Date: 10/01/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2015
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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