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

Model Number	YM101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: OXIMETER
• Manufacturer (Section D): SHENZHEN YIMI LIFE TECHNOLOGY CO., LTD.
• MDR Report Key: 10074948
• Report Number: MW5094583
• Device Sequence Number: 3732139
• Product Code: DQA
• UDI-Device Identifier: 06972911370012
• UDI-Public: (01)06972911370012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/16/2020

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
• Operator of Device: No Information
• Device Model Number: YM101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1