MAUDE Adverse Event Report: INNOVO MEDICAL INNOVO FINGER TIP OXMETER MODEL IP900AP; OXIMETER, INFRARED, SPORTING, AVIATION

Model Number	IP900AP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This has happened many times today being the most recent.The innovo fingertip pulse oximeter ip900ap gives very false readings and on one occasion while taking spo/pulse readings it was ranging from 132 down to 32 for quite some time.I was so concerned i called the para-medics and was rushed to the emergency room where dr.Said everything looked fine.I called innovo to report this and they said it sounds like the meter was going bad, no offer to replace it or give a discount on another unit just it's going bad.Today i took readings and it was ranging from132 down to 32 so i took another brand of oximeter i have and took reading and it said 62 steady tried it with yet another brand of oximeter i had and it read 69, then took it again with the innovo and it read 113.This is not a dependable health monitoring device.I sill have the product but don't know how to upload a picture.

• Brand Name: INNOVO FINGER TIP OXMETER MODEL IP900AP
• Common Device Name: OXIMETER, INFRARED, SPORTING, AVIATION
• Manufacturer (Section D): INNOVO MEDICAL
• MDR Report Key: 16645764
• Report Number: MW5116133
• Device Sequence Number: 5821910
• Product Code: OCH
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/27/2023

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: Lay User/Patient
• Device Model Number: IP900AP
• Device Catalogue Number: M430N-PEWH-JPIM
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White