MAUDE Adverse Event Report: UNKNOWN PORTO MOBILITY RANGER D09; WHEELCHAIR, POWERED

Model Number RANGER D09

Device Problems Device Alarm System (1012); Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2022

Event Type  malfunction  

Event Description

Purchased product from www.Portomobility.Com product was not working and just kept on beeping, went online and it appears the company portola tech llc (porto mobility), (b)(6) is not registered with the fda but is selling a class ii medical device.This needs to be seriously looked at to verify they are taking care of their product quality and customers!! portola tech llc.Diabetes, high blood pressure.

• Brand Name: PORTO MOBILITY RANGER D09
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16027069
• MDR Text Key: 306160033
• Report Number: MW5113924
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RANGER D09
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: FISH OIL, MULTI VITAMINS.; INSULIN, ZESTRIL.
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 166 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White