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

Model Number PRO-TF200

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

Device discarded by end user.

Event Description

On (b)(6) 2016, end user customer (b)(6) called regarding a caregiver thermometer that overheated.Customer complained that thermometer got really hot and left a mark on the operator which went away the next day without medical intervention.Customer requested a replacement thermometer which was provided.On 12/9/12016, (b)(4) spoke with customer.She said it was an old device, perhaps 4 years old and batteries would have been changed from the original ones which were supplied by (b)(4).Customer discarded the thermometer and batteries, so (b)(4) was unable to ascertain manufacturer of batteries and was unable to investigate the cause of the malfunction.

• Brand Name: CAREGIVER THERMOMETER
• Type of Device: INFRARED NON-CONTACT THERMOMETER
• Manufacturer (Section D): THERMOMEDICS, INC.; 18310 calle la serra; rancho santa fe, ca. 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: 6215770
• MDR Text Key: 63660022
• Report Number: 3008872366-2016-00002
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/28/2016

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-TF200
• Device Catalogue Number: PRO-TF200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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