MAUDE Adverse Event Report: BESTMED, LLC / K-JUMP HEALTH CO., LTD. DIGITAL THERMOMETER; THERMOMETER, ELECTRONIC

Model Number KI-8190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem Alteration In Body Temperature (2682)

Event Date 09/29/2016

Event Type  Injury  

Event Description

My child had been come down with a fever so i went into a (b)(6), i bought the digital thermometer.I read her temp at 102 so i gave her medicine to reduce the fever.I took it again when she warmed up and it was slightly lower.I didn't take her in to the hospital immediately.After she began to have fast breathing and a pounding chest did i take her in.She was actually 3 degrees higher than what the thermometer indicated.My child was at a 104 when we hit the er.She had been possibly at a 105 while i'm thinking the thermometer was correct.She had pneumonia and was treated.

• Brand Name: DIGITAL THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC
• Manufacturer (Section D): BESTMED, LLC / K-JUMP HEALTH CO., LTD.
• MDR Report Key: 6883211
• MDR Text Key: 87155242
• Report Number: MW5072253
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KI-8190
• Device Lot Number: 1410
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 14 MO
• Patient Weight: 11