MAUDE Adverse Event Report: BESTMED LLC, K-JUMP HEALTH CO. TEMPLE THERMOMETER DDT

Model Number KD-2201

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

During repeated assessments, the thermometer registered inaccurate temp readings.The pts temps were taken axillary until the new thermometer was purchased.Dtt temple thermometer used per shift every 4 hours.Dates of use: (b)(6) 2015 - (b)(6) 2016.Diagnosis or reason for use: congenital myopathy.Event abated after use stopped or dose reduced: yes.

• Brand Name: TEMPLE THERMOMETER DDT
• Type of Device: TEMPLE THERMOMETER
• Manufacturer (Section D): BESTMED LLC, K-JUMP HEALTH CO. ; golden CO 80401
• MDR Report Key: 6689057
• MDR Text Key: 79264629
• Report Number: MW5070810
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/03/2017

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: Health Professional
• Device Expiration Date: 02/17/2016
• Device Model Number: KD-2201
• Device Lot Number: KD-2201
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 15