MAUDE Adverse Event Report: OXILINE LLC. PULSE OXIMETER OXILINE

Model Number PULSE X PRO - MODEL#JKS50C

Device Problem Use of Device Problem (1670)

Patient Problems Low Oxygen Saturation (2477); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/16/2022

Event Type  Injury  

Event Description

I am recently diagnosed with congestive heart failure and as also diagnosed with low oxygen saturation (desat <90 at rest and with activity).Advised by physician to obtain consumer grade oximeter that has fda 510(k) clearance.Found online - a company called oxiline, who's websites reports that all their medical devices have this 510(k) clearance.Purchased medical device based on their website assurance, and relied on the device to make medical decisions on treatment (ie.Do need supplemental with 02 which was supplied by physician).I can find no such fda 510(k) approval for my device (pulse x pro - model#jks50c).Request emergency assistance, fda enforcement actions to prevent further sales of this product, recalls, and other punitive actions you deem necessary to prevent further harm to us citizens.Fda safety report id# (b)(4).

• Brand Name: PULSE OXIMETER OXILINE
• Type of Device: OXIMETER
• Manufacturer (Section D): OXILINE LLC.
• MDR Report Key: 14946200
• MDR Text Key: 295497392
• Report Number: MW5110709
• 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: Patient
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PULSE X PRO - MODEL#JKS50C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BIPAP; HOME OXYGEN ; HYDRAZALINE; INSULIN ; METOPROLOL
• Patient Outcome(s): Life Threatening; Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 154 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White