MAUDE Adverse Event Report: SHENZHEN YIMI LIFE TECHNOLOGY CO., LTD. FINGERTIP PULSE OXIMETER

Model Number YM101

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/11/2020

Event Type  malfunction  

Event Description

We purchased a (shenzhen yimi life technologies) finger tip pulse oximeter through (b)(6).I am writing with several concerns: the marketing material on (b)(6) indicated the product would work for adults and children, the marketing materials included with the product indicate for adult use only; the product is labeled rx only but (b)(6) never asked for a copy of a prescription; is (b)(6) vawd certified enabling them to sell prescription devices?; shenzhen yimi life does not appear to have a presence in the u.S.A; the package insert lists validation test results based on a sample of eleven patients; is this sample statistically significant? fda safety report id# (b)(4).

• Brand Name: FINGERTIP PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): SHENZHEN YIMI LIFE TECHNOLOGY CO., LTD.
• MDR Report Key: 10074948
• MDR Text Key: 191815775
• Report Number: MW5094583
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 06972911370012
• UDI-Public: (01)06972911370012
• 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
• Type of Report: Initial
• Report Date: 05/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: YM101
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1