MAUDE Adverse Event Report: SHENZHEN YIMI LIFE TECHNOLOGY CO.,LTD YM101 PULSE OXIMETER

Model Number YM101

Device Problem Output Problem (3005)

Patient Problem Bradycardia (1751)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

I had a bradycardia episode and noticed that, when my heart rate was at 50bpm or less, the device was often reporting my heart rate as being the double of its effective value.Luckily, i had other devices (portable ekg, cuff, and apple watch) that all reported my low hr properly and helped me take the right next steps.Fda safety report id # (b)(4).

• Brand Name: YM101 PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): SHENZHEN YIMI LIFE TECHNOLOGY CO.,LTD
• MDR Report Key: 12518517
• MDR Text Key: 273312251
• Report Number: MW5104153
• Device Sequence Number: 1
• Product Code: DQA
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: YM101
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 75