MAUDE Adverse Event Report: DAATRICS LTD NEEBO HEART RATE AND OXYGEN MONITOR; OXIMETER

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 08/01/2018

Event Type  No Answer Provided  

Event Description

Submitter says that the product does not work.The algorithms regarding the oxygen are not responsive enough to detect drops in oxygen levels.Retailer: neebomonitor.Com, state: (b)(6).Purchase date: (b)(6) 2018, this date is an estimate.The product was not damaged before the incident.The product was not modified before the incident.(b)(4).

• Brand Name: NEEBO HEART RATE AND OXYGEN MONITOR
• Type of Device: OXIMETER
• Manufacturer (Section D): DAATRICS LTD
• MDR Report Key: 9310558
• MDR Text Key: 166214671
• Report Number: MW5090991
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1