MAUDE Adverse Event Report: THERMOMEDICS, INC. CAREGIVER; THERMOMETER, ELECTRONIC, CLINICAL, INFRARED

Model Number PRO-TF200

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2015

Event Type  malfunction  

Event Description

Nurse noticed that thermometer was getting increasingly hotter and took the thermometer out of the patient room to the nurses station.It got hot enough to melt the plastic.Staff contacted biomed and unit had eventually cooled off when the biomed tech arrived on the unit a few minutes later.

• Brand Name: CAREGIVER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL, INFRARED
• Manufacturer (Section D): THERMOMEDICS, INC.; 18310 calle la serra; rancho santa fe CA 92091
• MDR Report Key: 5126861
• MDR Text Key: 27427956
• Report Number: 5126861
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PRO-TF200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1