MAUDE Adverse Event Report: BAI LU HEALTH CO., LTD.8 INFRARED DIGITAL EAR THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/15/2018

Event Type  Injury  

Event Description

(b)(4).Manufacturers and distributes infrared digital ear thermometer does not meet performance specifications, making the device violative.Multiple request submitted requesting (b)(4) voluntary recall and file 806 report.Continued use of devices could lead to death or serious injury.Febrile patients is vital criterion in diagnosis of many systemic disease process, such as septic shock.Pediatric and older adults are at increased risk for thermo-irregularities therefore the use of this device in the home setting delays treatment if left untreated results in hospitalization.

• Brand Name: INFRARED DIGITAL EAR THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): BAI LU HEALTH CO., LTD.8
• MDR Report Key: 7439465
• MDR Text Key: 105935514
• Report Number: MW5076533
• Device Sequence Number: 0
• Product Code: FLL
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR